Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief summary
The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.
Detailed description
To determine the clinical activity of 177Lu -J591 for the treatment of patients with metastatic, androgen-independent prostate cancer. Patients will receive a single dose of J591 (total antibody of 20 mg) consisting of antibody chelated with 177Lu at a dose of 65 or 70 mCi/m2 with a specific activity of 12-15 mCi/mg plus non-radiolabeled antibody.
Interventions
DRUG177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic diagnosis of prostate adenocarcinoma. * Metastatic prostate cancer progressive on imaging studies and/or rising PSA despite adequate medical or surgical castration therapy. * Progressed following discontinuation of anti-androgen therapy, if received. * Serum testosterone \< 50 ng/ml
Exclusion criteria
* Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment. * Use of PC-SPES within 4 weeks of treatment. * Use of red blood cell or platelet transfusions within 4 weeks of treatment. * Use of hematopoietic growth factors within 4 weeks of treatment. * Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment. * Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton. * Prior radiation therapy encompassing \>25% of skeleton. * Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®). * Active angina pectoris or NY Heart Association Class III-IV. * History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months of study entry. * Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study. * Prior monoclonal antibody therapy with the exception of ProstaScint® * Prior investigational therapy (medications or devices) within 6 weeks of treatment. * Known history of HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Define the PSA Response Rate. | At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks | PSA response rate corresponds to change form baseline in PSA at any of the time points specified. |
| Define the Measurable Disease Response Rate. | Disease will be assessed at baseline and day 85. | Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Define the Incidence of Human Anti-J591 Antibody (HAHA) Response. | HAHA samples will be drawn at baseline and Day 85. | — |
| Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index). | Bone scan will be performed at baseline and Day 85. | Bone scan score determined for each patient and related to the degree of hematological toxicity quantified by % decline of nadir platelet count relative to baseline count. |
| Define the Duration of Biochemical PSA and/or Measurable Disease Response. | At baseline, and up to death | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, Complete Response (CR) = Disappearance of all target lesions, Partial Response (PR) = A \</=30% decrease in the sum of the longest diameter of target lesions, taking as reference the Baseline sum longest diameter, Stable Disease (SD) = Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, Progressive Disease (PD) = A \>/=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions |
| Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites. | Scans will be performed between day 6 and 8. | — |
| Assess the Survival Rate of Patients Following Treatment. | From baseline through study completion | — |
| Define the Toxicity of 177Lu-J591 Given as Single Dose. | From baseline until end of treatment phase (12 weeks) | Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 73.9 years |
| Alkaline phosphatase | 99 IU/L |
| Cancer And Leukemia Group B (CALGB) prognostic score | 149 points |
| ECOG performance scale 0 | 13 Participants |
| ECOG performance scale 1 | 34 Participants |
| ECOG performance scale 2 | 0 Participants |
| Gleason sum 6 | 6 participants |
| Gleason sum 7 | 10 participants |
| Gleason sum 8-10 | 29 participants |
| Gleason sum unknown | 2 participants |
| Hemoglobin | 11.9 g/dL |
| LDH | 217.5 IU/L |
| No. of previous chemotherapy regimens 0 | 21 Participants |
| No. of previous chemotherapy regimens 1 | 19 Participants |
| No. of previous chemotherapy regimens >/= 2 | 7 Participants |
| No. of previous hormonal therapies 1 | 6 Participants |
| No. of previous hormonal therapies 2 | 21 Participants |
| No. of previous hormonal therapies 3 | 14 Participants |
| No. of previous hormonal therapies 4 | 6 Participants |
| Prior radiation Other | 1 Participants |
| Prior radiation Palliative to bone metastasis | 3 Participants |
| Prior radiation Prostate/prostate bed | 21 Participants |
| PSA (ng/mL) | 74.4 ng/mL |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 47 Participants |
| Sites of metastases Bone | 46 Participants |
| Sites of metastases Liver | 4 Participants |
| Sites of metastases Lung | 11 Participants |
| Sites of metastases Lymph Node | 28 Participants |
| Sites of metastases Other | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 47 |
| serious Total, serious adverse events | 9 / 47 |
Outcome results
Primary
Define the Measurable Disease Response Rate.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Time frame: Disease will be assessed at baseline and day 85.
Population: Only 12 patients had measurable disease
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Patients | Define the Measurable Disease Response Rate. | Partial Response | 1 Participants |
| All Patients | Define the Measurable Disease Response Rate. | Stable Disease | 8 Participants |
| All Patients | Define the Measurable Disease Response Rate. | Progressive Disease | 2 Participants |
| All Patients | Define the Measurable Disease Response Rate. | Lost to follow-up before repeat imaging | 1 Participants |
Primary
Define the PSA Response Rate.
PSA response rate corresponds to change form baseline in PSA at any of the time points specified.
Time frame: At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Patients | Define the PSA Response Rate. | >/= 50% decline in PSA | 5 Participants |
| All Patients | Define the PSA Response Rate. | >/= 30% decline in PSA | 17 Participants |
| All Patients | Define the PSA Response Rate. | Any PSA decline | 25 Participants |
Secondary
Assess the Survival Rate of Patients Following Treatment.
Time frame: From baseline through study completion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Assess the Survival Rate of Patients Following Treatment. | 17.6 months |
Secondary
Define the Duration of Biochemical PSA and/or Measurable Disease Response.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, Complete Response (CR) = Disappearance of all target lesions, Partial Response (PR) = A \</=30% decrease in the sum of the longest diameter of target lesions, taking as reference the Baseline sum longest diameter, Stable Disease (SD) = Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, Progressive Disease (PD) = A \>/=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions
Time frame: At baseline, and up to death
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Patients | Define the Duration of Biochemical PSA and/or Measurable Disease Response. | Any PSA decline | 22.2 months |
| All Patients | Define the Duration of Biochemical PSA and/or Measurable Disease Response. | Without PSA decline | 11.4 months |
Secondary
Define the Incidence of Human Anti-J591 Antibody (HAHA) Response.
Time frame: HAHA samples will be drawn at baseline and Day 85.
Population: Samples were collected but data necessary to summarize this outcome measure was not collected because the study team felt that there was adequate data from previous phase I studies, including repeating dosing of the study drug in this study and others that were performed prior to this study's completion.
Secondary
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time frame: From baseline until end of treatment phase (12 weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Taste alteration (dysquesia) | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Weight loss | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Hemoglobin | Grade 1-2 | 19 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Hemoglobin | Grade 3 | 5 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Hemoglobin | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Hemoglobin | No toxicity | 23 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : ALT | Grade 1-2 | 6 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : ALT | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Anorexia | Grade 1-2 | 11 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Anorexia | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Anorexia | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Anorexia | No toxicity | 36 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Bruising (no thrombocytopenia) | Grade 1-2 | 2 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Bruising (no thrombocytopenia) | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Bruising (no thrombocytopenia) | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Bruising (no thrombocytopenia) | No toxicity | 45 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Constipation | Grade 1-2 | 5 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Constipation | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Constipation | No toxicity | 42 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Creatinine | Grade 1-2 | 5 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Creatinine | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Creatinine | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Creatinine | No toxicity | 42 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Diarrhea | Grade 1-2 | 4 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Diarrhea | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Diarrhea | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Diarrhea | No toxicity | 43 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dizziness | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dizziness | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dizziness | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dizziness | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dyspepsia | Grade 1-2 | 2 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dyspepsia | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dyspepsia | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dyspepsia | No toxicity | 45 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dyspnea | Grade 1-2 | 3 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dyspnea | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dyspnea | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Dyspnea | No toxicity | 44 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Edema: limb | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Edema: limb | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Edema: limb | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Fatigue | Grade 1-2 | 17 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Fatigue | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Fatigue | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Fatigue | No toxicity | 30 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Fever (without neutropenia) | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Fever (without neutropenia) | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Fever (without neutropenia) | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Fever (without neutropenia) | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Hemorrhage, GI: oral cavity | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Hemorrhage, GI: oral cavity | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Hemorrhage, GI: oral cavity | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Hemorrhage, GI: oral cavity | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic: Hypersensitivity,infusion reaction | Grade 1-2 | 11 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic: Hypersensitivity,infusion reaction | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic: Hypersensitivity,infusion reaction | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic: Hypersensitivity,infusion reaction | No toxicity | 36 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Nausea | Grade 1-2 | 5 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Nausea | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Nausea | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Pain - abdomen NOS | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Pain - abdomen NOS | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Pain - abdomen NOS | No toxicity | 45 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Pain - joint | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Pain - joint | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Pain - joint | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Pain - joint | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Petechiae/purpura | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Petechiae/purpura | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Petechiae/purpura | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Petechiae/purpura | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Rash/desquamation | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Rash/desquamation | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Rash/desquamation | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Rash/desquamation | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Leukocytes (total WBC) | Grade 3 | 22 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Leukocytes (total WBC) | Grade 4 | 4 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Leukocytes (total WBC) | No toxicity | 7 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Neutrophils (ANC) | Grade 1-2 | 7 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Neutrophils (ANC) | Grade 3 | 17 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Neutrophils (ANC) | Grade 4 | 12 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Neutrophils (ANC) | No toxicity | 11 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Febrile neutropenia | Grade 1-2 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Febrile neutropenia | Grade 3 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Febrile neutropenia | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Febrile neutropenia | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Platelets | Grade 1-2 | 4 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Platelets | No toxicity | 11 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Rigors/chills | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Rigors/chills | No toxicity | 46 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Taste alteration (dysquesia) | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Taste alteration (dysquesia) | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : ALT | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : ALT | No toxicity | 41 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : AST | Grade 1-2 | 9 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : AST | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : AST | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : AST | No toxicity | 38 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Constipation | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Edema: limb | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Nausea | No toxicity | 42 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Pain - abdomen NOS | Grade 1-2 | 2 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Rigors/chills | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Rigors/chills | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Taste alteration (dysquesia) | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Weight loss | Grade 1-2 | 1 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Weight loss | Grade 3 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Nonhematologic : Weight loss | Grade 4 | 0 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Leukocytes (total WBC) | Grade 1-2 | 14 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Platelets | Grade 3 | 10 Participants |
| All Patients | Define the Toxicity of 177Lu-J591 Given as Single Dose. | Hematologic : Platelets | Grade 4 | 22 Participants |
Secondary
Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index).
Bone scan score determined for each patient and related to the degree of hematological toxicity quantified by % decline of nadir platelet count relative to baseline count.
Time frame: Bone scan will be performed at baseline and Day 85.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index). | 0 participants |
Secondary
Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites.
Time frame: Scans will be performed between day 6 and 8.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Patients | Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites. | 44 Participants |