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 rebeccamycin analog in treating patients who have advanced kidney cancer.
Detailed description
OBJECTIVES: * Determine the response rate of patients with advanced renal cell carcinoma when treated with rebeccamycin analogue. * Assess the quantitative and qualitative toxicities associated with this drug in this patient population. OUTLINE: Patients receive rebeccamycin analogue IV over 30-60 minutes daily for 5 days. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 9-18 months.
Interventions
DRUGbecatecarin
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
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 locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma not eligible for a higher priority trial * Measurable disease * Longest diameter at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan * No nonmeasurable disease only including: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Abdominal masses not confirmed and followed by imaging techniques * Cystic lesions * No known brain metastases * History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy: * Greater than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST/ALT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue * No other concurrent uncontrolled illness (e.g., ongoing or active infection) * No concurrent psychiatric illness or social situation that would preclude study compliance * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior biologic therapy allowed * Recovered from toxic effects Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics Other: * No other concurrent investigational or commercial agents or therapies for renal cell cancer
Countries
United States
Outcome results
None listed