This trial is active, not recruiting.

Condition kidney cancer
Treatment 7-hydroxystaurosporine
Phase phase 2
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

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).