UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
This trial is active, not recruiting.
|Sponsor||University of California, San Francisco|
|Collaborator||National Cancer Institute (NCI)|
|Start date||December 2002|
|Trial identifier||NCT00030888, CDR0000069208, NCI-5522, UCSF-NCI-5522|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Male or female participants at least 18 years old.
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
|Official title||A Phase 2 Study Of UCN-01 In Advanced Renal Cell Carcinoma|
|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.|
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