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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 2 Locations for this study
San Francisco California, 94115, United States
San Francisco California, 94121, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.