Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer, recurrent renal cell cancer
Brief summary
RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.
Detailed description
OBJECTIVES: * Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b. * Determine the toxicity of this regimen in these patients. * Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies. OUTLINE: This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b. (Phase I closed to accrual as of 9/24/03.) Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days (M-F) for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined additional patients are accrued and treated at that dose. (Phase I closed to accrual as of 9/24/03.) During the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose escalations. After week 3, patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study. (Phase I closed to accrual as of 9/24/03.) Patients are followed at 30 days after the last treatment. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued into the phase I portion of this study (Phase I closed to accrual as of 9/24/03). A total of 14-25 patients will be accrued into the phase II portion of this study.
Interventions
BIOLOGICALrecombinant interferon alfa
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * Bidimensionally measurable disease * No active brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * No coagulation disorders Hepatic: * Bilirubin less than 1.5 mg/dL * SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal * No clinically significant hepatic disease, including autoimmune hepatitis Renal: * Creatinine less than 2 mg/dL OR * Creatinine clearance greater than 50 mL/min * No clinically significant renal disease Cardiovascular: * No clinically significant cardiac disease * No thrombophlebitis Pulmonary: * No severe debilitating pulmonary disease * No pulmonary embolism Other: * No history of diabetes mellitus prone to ketoacidosis * No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study * No thyroid abnormalities that hinder maintaining thyroid function at the normal range * No severe infection * No severe malnutrition * No clinically significant retinal abnormalities * No pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder * No other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective methods of contraception during and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior biological response modifier therapy or immunotherapy Chemotherapy: * No more than 1 prior chemotherapy regimen Endocrine therapy: * No concurrent steroids Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * No prior retinoid therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Response as Measured by CT, Bone Scans, and Clinical Progression | After 8 weeks |
| Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | In 30 days after the last dose, an average of 1 year. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose | At baseline and 5th week |
| Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response | At 6 months and 12 months |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from between April 2002 and March 2005. Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 Group Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome | 12 |
| Phase 2 Group Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome | 14 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Phase 1 Group | Phase 2 Group | Total |
|---|---|---|---|
| Age, Customized Median age | 66.5 years | 61.1 years | 63.6 years |
| Histology Clear cell | 7 Participants | 9 Participants | 16 Participants |
| Histology Clear cell with sarcomatoid features | 1 Participants | 4 Participants | 5 Participants |
| Histology Papillary | 1 Participants | 0 Participants | 1 Participants |
| Histology Unclassified | 3 Participants | 0 Participants | 3 Participants |
| Histology Xp11 | 0 Participants | 1 Participants | 1 Participants |
| Number of patients with metastases at the time of diagnosis | 6 Participants | 8 Participants | 14 Participants |
| Prior nephrectomy No prior nephrectomy | 0 Participants | 2 Participants | 2 Participants |
| Prior nephrectomy Yes prior nephrectomy | 12 Participants | 12 Participants | 24 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 12 / 12 | 14 / 14 |
| serious Total, serious adverse events | 1 / 12 | 0 / 14 |
Outcome results
Primary
Best Response as Measured by CT, Bone Scans, and Clinical Progression
Time frame: After 8 weeks
Population: Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Partial Response | 1 Participants |
| Phase 1 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Minor Reponse | 0 Participants |
| Phase 1 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Stable Disease | 5 Participants |
| Phase 1 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Disease Progression | 5 Participants |
| Phase 1 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Complete Response | 1 Participants |
| Phase 2 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Disease Progression | 6 Participants |
| Phase 2 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Complete Response | 0 Participants |
| Phase 2 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Minor Reponse | 1 Participants |
| Phase 2 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Partial Response | 3 Participants |
| Phase 2 Group | Best Response as Measured by CT, Bone Scans, and Clinical Progression | Stable Disease | 4 Participants |
Primary
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Time frame: In 30 days after the last dose, an average of 1 year.
Population: Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Leukopenia : Grade 3 | 3 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Constipation : Grade 1 | 5 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Leukopenia : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anorexia : Grade 1 | 9 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fever : Grade 1 | 4 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fatigue : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fever : Grade 2 | 1 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anorexia : Grade 2 | 2 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fever : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Constipation : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fever : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anorexia : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Renal : Grade 1 | 1 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Skin : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Renal : Grade 2 | 1 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anorexia : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Renal : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Constipation : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Renal : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Neurologic : Grade 1 | 8 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Liver : Grade 1 | 1 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Skin : Grade 1 | 1 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Liver : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Neurologic : Grade 2 | 3 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Liver : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Constipation : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Liver : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Neurologic : Grade 3 | 1 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Thrombocytopenia : Grade 1 | 2 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Xeroderma : Grade 1 | 11 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Thrombocytopenia : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Neurologic : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Thrombocytopenia : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cough : Grade 1 | 4 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Thrombocytopenia : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Diarrhea : Grade 1 | 5 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Infusion reaction : Grade 1 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fatigue : Grade 2 | 5 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Infusion reaction : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Diarrhea : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Infusion reaction : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cough : Grade 2 | 2 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Infusion reaction : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Diarrhea : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Pulmonary : Grade 1 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Xeroderma : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Pulmonary : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Diarrhea : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Pulmonary : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cough : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Pulmonary : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nausea/vomiting : Grade 1 | 2 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nasal congestion : Grade 1 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Skin : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nasal congestion : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nausea/vomiting : Grade 2 | 2 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nasal congestion : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cough : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nasal congestion : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nausea/vomiting : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Hypotension : Grade 1 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Xeroderma : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Hypotension : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nausea/vomiting : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Hypotension : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anemia : Grade 1 | 3 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Hypotension : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Altered mood : Grade 1 | 8 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cholesterol/TG : Grade 1 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fatigue : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cholesterol/TG : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Altered mood : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cholesterol/TG : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anemia : Grade 2 | 1 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cholesterol/TG : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Altered mood : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Bone pain : Grade 1 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Xeroderma : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Bone pain : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Altered mood : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Bone pain : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anemia : Grade 3 | 2 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Bone pain : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Leukopenia : Grade 1 | 2 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Other pain : Grade 1 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Skin : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Other pain : Grade 2 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Leukopenia : Grade 2 | 2 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Other pain : Grade 3 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anemia : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Other pain : Grade 4 | 0 Participants |
| Phase 1 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fatigue : Grade 1 | 7 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Other pain : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fatigue : Grade 1 | 8 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fatigue : Grade 2 | 4 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fatigue : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fatigue : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Skin : Grade 1 | 3 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Skin : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Skin : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Skin : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Xeroderma : Grade 1 | 5 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Xeroderma : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Xeroderma : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Xeroderma : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Constipation : Grade 1 | 4 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Constipation : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Constipation : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Constipation : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cough : Grade 1 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cough : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cough : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cough : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anemia : Grade 1 | 2 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anemia : Grade 2 | 5 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anemia : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anemia : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anorexia : Grade 1 | 6 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anorexia : Grade 2 | 2 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anorexia : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Anorexia : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Neurologic : Grade 1 | 9 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Neurologic : Grade 2 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Neurologic : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Neurologic : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Diarrhea : Grade 1 | 4 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Diarrhea : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Diarrhea : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Diarrhea : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nausea/vomiting : Grade 1 | 6 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nausea/vomiting : Grade 2 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nausea/vomiting : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nausea/vomiting : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Altered mood : Grade 1 | 4 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Altered mood : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Altered mood : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Altered mood : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Leukopenia : Grade 1 | 2 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Leukopenia : Grade 2 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Leukopenia : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Leukopenia : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fever : Grade 1 | 5 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fever : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fever : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Fever : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Renal : Grade 1 | 3 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Renal : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Renal : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Renal : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Liver : Grade 1 | 2 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Liver : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Liver : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Liver : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Thrombocytopenia : Grade 1 | 3 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Thrombocytopenia : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Thrombocytopenia : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Thrombocytopenia : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Infusion reaction : Grade 1 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Infusion reaction : Grade 2 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Infusion reaction : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Infusion reaction : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Pulmonary : Grade 1 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Pulmonary : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Pulmonary : Grade 3 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Pulmonary : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nasal congestion : Grade 1 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nasal congestion : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nasal congestion : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Nasal congestion : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Hypotension : Grade 1 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Hypotension : Grade 2 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Hypotension : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Hypotension : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cholesterol/TG : Grade 1 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cholesterol/TG : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cholesterol/TG : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Cholesterol/TG : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Bone pain : Grade 1 | 1 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Bone pain : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Bone pain : Grade 3 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Bone pain : Grade 4 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Other pain : Grade 1 | 5 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Other pain : Grade 2 | 0 Participants |
| Phase 2 Group | Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose | Other pain : Grade 3 | 0 Participants |
Secondary
Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose
Time frame: At baseline and 5th week
Population: Phase 1 portion at the RP2D of 90 mg/m2. 6 patients (12 in phase 1 w 6 at 75 mg/m2 and 6 at 90 mg/m2). This was not completed on the other 14 in phase 2 portion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Group | Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose | 0 Participants |
Secondary
Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response
Time frame: At 6 months and 12 months
Population: Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Group | Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response | 6 month | 5 Participants |
| Phase 1 Group | Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response | 12 month | 4 Participants |
| Phase 2 Group | Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response | 6 month | 7 Participants |
| Phase 2 Group | Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response | 12 month | 3 Participants |