NCT00030888

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2002

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2002

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 6, 2014

Status Verified

December 1, 2003

First QC Date

February 14, 2002

Last Update Submit

January 3, 2014

Conditions

Kidney Cancer

Keywords

stage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancer

Interventions

7-hydroxystaurosporineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

7-hydroxystaurosporine

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Brian I. Rini, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

December 1, 2002

Last Updated

January 6, 2014

Record last verified: 2003-12

Locations

US(2)