Kidney Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Study ID:

NCT00030888

Recruitment Status:

Unknown status

Sponsor:

University of California, San Francisco

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There are 2 Locations for this study

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UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States
Veterans Affairs Medical Center - San Francisco
San Francisco California, 94121, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Study ID:

NCT00030888

Recruitment Status:

Unknown status

Sponsor:


University of California, San Francisco

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