search
Back to results

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

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
7-hydroxystaurosporine
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center
  • Veterans Affairs Medical Center - San Francisco

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
January 3, 2014
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00030888
Brief Title
UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
Official Title
A Phase 2 Study Of UCN-01 In Advanced Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
7-hydroxystaurosporine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian I. Rini, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Veterans Affairs Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs