Expired Study
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Tampa, Florida 33612


Purpose:

RATIONALE: Tretinoin may help cells that are involved in the body's immune response to work better. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving tretinoin together with interleukin-2 may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving three different doses of tretinoin together with interleukin-2 works in treating patients with stage IV kidney cancer.


Study summary:

OBJECTIVES: Primary - Determine the ratio of dendritic cells (DC) to circulating immature cells (ImC) before and after treatment with 3 different doses of tretinoin in patients with stage IV renal cell cancer. - Assess in vitro immune response assays to tetanus toxoid and influenza virus peptide before and after treatment with tretinoin and interleukin-2 in these patients. Secondary - Determine the frequency of treatment-related side effects in these patients. - Determine clinical objective response and progression-free survival of patients treated with this regimen. - Correlate DC:ImC ratio with clinical objective response in patients treated with this regimen. - Correlate the extent of change of the DC:ImC ratio with tretinoin dose and tretinoin blood levels in these patients. OUTLINE: This is a randomized, open-label study. Specimens are stratified according to patient prognostic factors, tumor bulk, and extent of dendritic cell to circulating immature cell ratio derangement. Patients are randomized to 1 of 3 tretinoin doses. Patients are followed for up to 2 years. PROJECTED ACCRUAL: A total of 27-36 patients (9-12 per treatment arm) will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed renal cell cancer - Stage IV disease - Histology with clear cell component - Metastatic OR incompletely resected disease - Non-measurable disease allowed - Underwent complete or partial nephrectomy more than 90 days ago - No unresected primary cancer - No more than 2 of the following adverse factors: - Hemoglobin < 10.0 g/dL - Corrected calcium > upper limit of normal (ULN) - Lactic dehydrogenase > 1.5 times ULN - Eastern Cooperative Oncology Group (ECOG) performance status 2 - Brain metastasis allowed provided more than 90 days of clinical and radiologic stability after the end of its active treatment PATIENT CHARACTERISTICS: Age - Over 18 Performance status - See Disease Characteristics - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - See Disease Characteristics - Serum glutamic oxaloacetic transaminase (SGOT) < 3 times normal - Bilirubin < 2 times normal Renal - See Disease Characteristics - Creatinine clearance > 40 mL/min Cardiovascular - None of the following cardiovascular conditions within the past year: - Uncontrolled hypertension - Myocardial infarction - Unstable angina - New York Heart Association class II-IV congestive heart failure - Serious cardiac arrhythmia requiring medication - Class II-IV peripheral vascular disease within the past year - Other clinically significant cardiovascular disease Immunologic - No history of immunodeficiency disease - No HIV infection - No ongoing serious infection Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use two methods of effective contraception during and for 1 month (for women) or 6 months (for men) after study treatment - Other prior malignancy allowed provided there is no evidence of active disease - No other medical contraindication to tretinoin or interleukin-2 - No serious non-healing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: Biologic therapy - At least 60 days since prior immunotherapy Chemotherapy - At least 60 days since prior cytotoxic chemotherapy Endocrine therapy - See Radiotherapy - No prior corticosteroids at > physiologic replacement doses for > 3 days within the past 90 days - Concurrent tamoxifen, toremifene, megestrol, or gonadotropin-releasing hormone agonists allowed - Concurrent inhaled steroids allowed Radiotherapy - More than 7 days since prior external-beam radiotherapy - No steroid requirement during radiotherapy Surgery - See Disease Characteristics - At least 30 days since other prior debulking surgery Other - Prior adjuvant therapy for resected, synchronous stage IV disease allowed - Prior adjuvant therapy allowed - Study therapy is not to be used as adjuvant therapy for completely resected late (> 1 year until identification) solitary site of disease metastasis or non-metastatic disease - No prior participation in this clinical study - At least 60 days since other prior anticancer drugs - Concurrent seizure medication allowed


NCT ID:

NCT00100906


Primary Contact:

Principal Investigator
Mayer Fishman, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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