17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Kidney Cancer

Phase 2

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT00093405
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die. 17-N-allylamino-17-demethoxygeldanamycin may also stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic kidney cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic papillary or clear cell renal cell carcinoma.

Secondary

* Determine the safety of this drug in these patients.

* Correlate tumor c-met expression with response in patients treated with this drug.

OUTLINE: This is an open-label study. Patients are stratified according to histology (papillary vs clear cell).

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-90 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 6-20 months (clear cell stratum) and 2-5 years (papillary stratum).

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-10-06
• Study First Submitted QC: 2004-10-07
• Study First Posted: 2004-10-08
• Status Verified: 2005-11
• Study Completion: 2005-11
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy (complete and partial response)

Secondary Outcome Measures

Name	Time	Method
Toxicity

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States