Kidney Cancer
Conditions
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of UCN-01 in treating patients who have unresectable stage III or stage IV kidney cancer.
Detailed description
OBJECTIVES: * Determine the efficacy of UCN-01, in terms of time to objective progression, in patients with stage IV or unresectable stage III renal cell carcinoma. * Determine the objective response rate in patients treated with this drug. OUTLINE: Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 21-61 patients will be accrued for this study within 15 months.
Interventions
Sponsors
National Cancer Institute (NCI)
University of California, San Francisco
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage IV or unresectable stage III renal cell carcinoma * Metastatic disease must be amenable to biopsy or appropriate for nephrectomy before study therapy * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No known prior or concurrent CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No history of clinically significant coronary artery disease * No symptomatic cardiac dysfunction * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Pulmonary: * No symptomatic pulmonary dysfunction Other: * No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 * No other uncontrolled concurrent illness * No active or ongoing infection * No known immune deficiency * No psychiatric illness or social situation that would preclude study compliance * No insulin-dependent diabetes mellitus * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No prior mediastinal radiation Surgery: * See Disease Characteristics * At least 4 weeks since prior nephrectomy Other: * No more than 2 prior systemic therapies for metastatic renal cell carcinoma * No other concurrent investigational agents
Countries
United States
Outcome results
None listed