High Risk Neuroblastoma
Conditions
Brief summary
This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be an effective treatment for neuroblastoma.
Detailed description
PRIMARY OBJECTIVES: I. To comprehensively define the safety profile of ch14.18 when administered with cytokines and isotretinoin in high-risk neuroblastoma patients after autologous stem cell transplant (ASCT). SECONDARY OBJECTIVES: I. To further describe and refine the event-free survival (EFS) and overall survival (OS) estimates and baseline characteristics for subjects receiving chl4.18 + cytokines + isotretinoin. II. To further describe the safety and toxicity of chl4.18 + cytokines + isotretinoin with focus on: a) number of courses delivered per patient; b) number of dose reductions or stoppage (ch14.18 and/or interleukin \[IL\]-2 \[aldesleukin\]); and c) number of toxic deaths. III. To further describe the immune reconstitution of patients following ASCT, based on laboratory data obtained just prior to, during, and after treatment with this regimen. IV. To obtain correlative laboratory data to evaluate and describe mechanisms related to response, toxicity of immune activation, and allergic phenomena. OUTLINE: Patients receive sargramostim subcutaneously (SC) or intravenously (IV) over 2 hours on days 0-13 of courses 1, 3, and 5; monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4; and isotretinoin orally (PO) twice daily (BID) on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5. Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4. Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
Interventions
BIOLOGICALAldesleukin
Given IV
OTHERDiagnostic Laboratory Biomarker Analysis
Correlative studies
BIOLOGICALDinutuximab
Given IV
DRUGIsotretinoin
Given PO
BIOLOGICALSargramostim
Given IV or SC
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients must be diagnosed with neuroblastoma, and categorized as high-risk at the time of diagnosis * At pre-ASCT evaluation, patients must meet the International Neuroblastoma Response Criteria (INRC) for complete response (CR), very good partial response (VGPR), or partial response (PR) for primary site, soft tissue metastases and bone metastases; patients who meet those criteria must also meet the protocol specified criteria for bone marrow response as outlined below: =\< 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy; patients who have no tumor seen on the prior bone marrow, and then have =\< 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible; (Note that, per INRC, this would have been defined as an overall response of progressive disease \[PD\]) * Prior to enrollment on ANBL0931, a determination of residual disease must be performed (tumor imaging studies including metaiodobenzylguanidine \[MIBG\] scan, computed tomography \[CT\] or magnetic resonance imaging \[MRI\], bone marrow aspiration and biopsy); this disease assessment is required for eligibility, and should be done preferably within 2 weeks but must be done within a maximum of 4 weeks before enrollment * Patients with residual disease are eligible; biopsy is not required * Patients must not have progressive disease except for protocol specified bone marrow response * All patients must have completed therapy including intensive induction chemotherapy followed by ASCT and radiotherapy to be eligible; radiotherapy may be waived for patients who either had a small adrenal mass which was completely resected upfront, or who never had an identifiable primary tumor * No more than 9 months from the date of starting the first induction chemotherapy after diagnosis to the date of ASCT except for the rare occasions as noted below; for tandem ASCT patients, this will be the date of the FIRST stem cell infusion; Exception: for those who are initially diagnosed as non-high risk neuroblastoma, but later converted (and/ or relapsed) to high risk neuroblastoma, the 9 months restriction should start from the date of induction therapy for high risk neuroblastoma (not from the initial induction therapy for non-high risk disease), to the date of ASCT * Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age; required patients must have a Lansky or Karnofsky performance scale score of \>= 50% * Patients must have a life expectancy of \>= 2 months (8 weeks) * Total absolute phagocyte count (APC = neutrophils + monocytes) is at least 1000/uL * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows: * 1 month to \< 6 months: 0.4 mg/dL * 6 months to \< 1 year: 0.5 mg/dL * 1 to \< 2 years: 0.6 mg/dL * 2 to \< 6 years: 0.8 mg/dL * 6 to \< 10 years: 1 mg/dL * 10 to \< 13 years: 1.2 mg/dL * 13 to \< 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female) * \>= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 5 x upper limit of normal (ULN) for age * SOS (sinusoidal obstruction syndrome, formerly known as veno-occlusive disease \[VOD\]), if present, should be stable or improving * Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 55% by radionuclide angiography * No evidence of dyspnea at rest * If pulmonary function tests (PFTs) are performed, forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) \> 60% by pulmonary function test * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * Central nervous system (CNS) toxicity \< grade 2
Exclusion criteria
* Females of childbearing potential must have a negative pregnancy test * Patients of childbearing potential must agree to use an effective birth control method * Female patients who are lactating must agree to stop breast-feeding * Patients must not have received prior anti-GD2 antibody therapy * Patients must not have received prior vaccine therapy administered as treatment of neuroblastoma not routine infectious disease vaccinations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Up to 6 courses of therapy | Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival (EFS) | From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 3 years | Event-free Survival (EFS) for all eligible patients enrolled on the study |
| Overall Survival (OS) | From enrollment until death, or until last contact with the patient, up to 3 years | Overall Survival (OS) for all eligible patients enrolled on the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin |
|---|---|
| Age, Categorical <=18 years | 103 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 4.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 82 Participants |
| Region of Enrollment United States | 105 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 104 / 104 |
| serious Total, serious adverse events | 103 / 104 |
Outcome results
Primary
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever).
Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.
Time frame: Up to 6 courses of therapy
Population: There was one patient that did not receive treatment, represented on the baseline form as withdrawal by patient, not included in outcome measure tabulation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Abdominal pain (10300), course 1 | 17.3077 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Abdominal pain (10300), course 2 | 5.0000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Abdominal pain (10300), course 3 | 6.1224 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Abdominal pain (10300), course 4 | 4.4444 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Abdominal pain (10300), course 5 | 5.6818 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Abdominal pain (10300), course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Allergic reaction (12000), Course 1 | 1.92308 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Allergic reaction (12000), Course 2 | 5.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Allergic reaction (12000), Course 3 | 3.06122 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Allergic reaction (12000), Course 4 | 2.22222 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Allergic reaction (12000), Course 5 | 1.13636 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Allergic reaction (12000), Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anal pain (12800), Course 1 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anal pain (12800), Course 2 | 1.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anal pain (12800), Course 3 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anal pain (12800), Course 4 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anal pain (12800), Course 5 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anal pain (12800), Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anaphylaxis (13100), Course 1 | 0.96154 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anaphylaxis (13100), Course 2 | 4.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anaphylaxis (13100), Course 3 | 1.02041 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anaphylaxis (13100), Course 4 | 3.33333 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anaphylaxis (13100), Course 5 | 1.13636 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Anaphylaxis (13100), Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Back pain (16200), Course 1 | 4.80769 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Back pain (16200), Course 2 | 5.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Back pain (16200), Course 3 | 3.06122 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Back pain (16200), Course 4 | 3.33333 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Back pain (16200), Course 5 | 4.54545 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Back pain (16200), Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Capillary leak syndrome (19800) - Course 1 | 0.96154 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Capillary leak syndrome (19800) - Course 2 | 4.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Capillary leak syndrome (19800) - Course 3 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Capillary leak syndrome (19800) - Course 4 | 2.22222 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Capillary leak syndrome (19800) - Course 5 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Capillary leak syndrome (19800) - Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chest wall pain (21400) - Course 1 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chest wall pain (21400) - Course 2 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chest wall pain (21400) - Course 3 | 1.02041 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chest wall pain (21400) - Course 4 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chest wall pain (21400) - Course 5 | 1.13636 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Chest wall pain (21400) - Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Fever (33900) - Course 1 | 21.1538 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Fever (33900) - Course 2 | 58.0000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Fever (33900) - Course 3 | 6.1224 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Fever (33900) - Course 4 | 31.1111 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Fever (33900) - Course 5 | 4.5455 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Fever (33900) - Course 6 | 1.2346 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Flank pain (34200) - Course 1 | 0.96154 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Flank pain (34200) - Course 2 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Flank pain (34200) - Course 3 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Flank pain (34200) - Course 4 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Flank pain (34200) - Course 5 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Flank pain (34200) - Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Hypotension (43600) - Course 1 | 9.6154 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Hypotension (43600) - Course 2 | 17.0000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Hypotension (43600) - Course 3 | 4.0816 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Hypotension (43600) - Course 4 | 14.4444 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Hypotension (43600) - Course 5 | 7.9545 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Hypotension (43600) - Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Neck pain (57800) - Course 1 | 0.96154 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Neck pain (57800) - Course 2 | 3.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Neck pain (57800) - Course 3 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Neck pain (57800) - Course 4 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Neck pain (57800) - Course 5 | 1.13636 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Neck pain (57800) - Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Non-cardiac chest pain (58600) - Course 1 | 0.96154 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Non-cardiac chest pain (58600) - Course 2 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Non-cardiac chest pain (58600) - Course 3 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Non-cardiac chest pain (58600) - Course 4 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Non-cardiac chest pain (58600) - Course 5 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Non-cardiac chest pain (58600) - Course 6 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain (60600) - Course 1 | 23.0769 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain (60600) - Course 2 | 16.0000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain (60600) - Course 3 | 13.2653 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain (60600) - Course 4 | 20.0000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain (60600) - Course 5 | 11.3636 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain (60600) - Course 6 | 1.2346 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain in extremity (60700) - Course 1 | 4.80769 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain in extremity (60700) - Course 2 | 4.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain in extremity (60700) - Course 3 | 3.06122 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain in extremity (60700) - Course 4 | 6.66667 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain in extremity (60700) - Course 5 | 2.27273 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Pain in extremity (60700) - Course 6 | 1.23457 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Peripheral sensory neuropathy (64100) - Course 1 | 0.96154 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Peripheral sensory neuropathy (64100) - Course 2 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Peripheral sensory neuropathy (64100) - Course 3 | 1.02041 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Peripheral sensory neuropathy (64100) - Course 4 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Peripheral sensory neuropathy (64100) - Course 5 | 0.00000 percentage of participants |
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). | Peripheral sensory neuropathy (64100) - Course 6 | 0.00000 percentage of participants |
Secondary
Event-free Survival (EFS)
Event-free Survival (EFS) for all eligible patients enrolled on the study
Time frame: From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 3 years
Population: All eligible patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Event-free Survival (EFS) | 67.6 percentage |
Secondary
Overall Survival (OS)
Overall Survival (OS) for all eligible patients enrolled on the study
Time frame: From enrollment until death, or until last contact with the patient, up to 3 years
Population: All eligible patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin | Overall Survival (OS) | 79.1 percentage |