Kidney Cancer
Conditions
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma
Brief summary
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die. 17-N-allylamino-17-demethoxygeldanamycin may also stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic kidney cancer.
Detailed description
OBJECTIVES: Primary * Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic papillary or clear cell renal cell carcinoma. Secondary * Determine the safety of this drug in these patients. * Correlate tumor c-met expression with response in patients treated with this drug. OUTLINE: This is an open-label study. Patients are stratified according to histology (papillary vs clear cell). Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-90 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 6-20 months (clear cell stratum) and 2-5 years (papillary stratum).
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Papillary OR clear cell histology * If other histologies are present, clear cell or papillary must be predominant * Metastatic disease * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No brain metastases unless previously treated with radiotherapy or surgery AND asymptomatic with no active brain metastases detectable by CT scan or MRI for ≥ 6 months PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * AST and ALT ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 2.0 times ULN Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No severe valvular disease Pulmonary * No severe debilitating pulmonary disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No allergy to egg or egg products * No history of allergic reactions attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) * No active or ongoing infection requiring IV antibiotics * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * No more than 1 prior cytokine-based regimen * No concurrent biologic therapy Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery Other * Recovered from prior therapy * No more than 1 prior non-cytokine-based regimen * No other prior systemic treatment regimens * No other concurrent cytotoxic therapy * No other concurrent anticancer therapy * No other concurrent investigational agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy (complete and partial response) | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | — |
Countries
United States