Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma
Brief summary
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.
Detailed description
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.
Interventions
Immunotherapy with interleukin-2
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Dendritic Cells (DC) to Circulating Immature Cells (ImC) Before and After Treatment | 1 year, 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Treatment-Related Side Effects | 1 year, 3 months | Review of adverse events utilizing Common Toxicity Criteria (CTC) V3. |
| Overall Response Rate (ORR) | 1 year, 3 months | Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Evaluate per-patient observed best clinical responses, after 11-12 weeks of treatment. |
Countries
United States