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Clinical Trial: UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
This study has been suspended.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage III renal cell cancer Stage IV Renal Cell Cancer recurrent renal cell cancer | Drug: UCN-01 Procedure: chemotherapy | Phase II |
MedlinePlus related topics: Cancer; Kidney Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of UCN-01 in Patients With Unresectable Advanced or Metastatic Renal Cell Carcinoma
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
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location Information
California
UCSF Comprehensive Cancer Center, San Francisco, California, 94115, United States
Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States
Brian I. Rini, MD, Study Chair, University of California, San Francisco
More Information
Record last reviewed: November 2003
Last Updated: October 13, 2004
Record first received: February 14, 2002
ClinicalTrials.gov Identifier: NCT00030888
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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