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UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
Study NCT00030888   Information provided by National Cancer Institute (NCI)
First Received: February 14, 2002   Last Updated: July 23, 2008   History of Changes

February 14, 2002
July 23, 2008
December 2002
 
 
 
Complete list of historical versions of study NCT00030888 on ClinicalTrials.gov Archive Site
 
 
 
UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
A Phase 2 Study Of UCN-01 In Advanced Renal Cell Carcinoma

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.

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.

Phase II
Interventional
Treatment
Kidney Cancer
Drug: 7-hydroxystaurosporine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00030888
 
CDR0000069208, UCSF-NCI-5522, NCI-5522
UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Brian I. Rini, MD UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP