UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 2 Study Of UCN-01 In Advanced Renal Cell Carcinoma

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: 7-hydroxystaurosporine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 7-hydroxystaurosporine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer