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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00093405
• Collaborator: National Cancer Institute (NCI) (NIH)
• Location: 1
• Duration (Months): 15

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Drug: tanespimycin	Phase 2

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 Design

• Study Type: Interventional
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG)In Metastatic Renal Cell Carcinoma
• Study Start Date: Aug 1, 2004
• Actual Study Completion Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

1. Efficacy (complete and partial response) []

Secondary Outcome Measures

1. Toxicity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Papillary OR clear cell histology

• If other histologies are present, clear cell or papillary must be predominant

• Metastatic disease

• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• No brain metastases unless previously treated with radiotherapy or surgery AND asymptomatic with no active brain metastases detectable by CT scan or MRI for ≥ 6 months

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• AST and ALT ≤ 1.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 2.0 times ULN

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No severe valvular disease

Pulmonary

• No severe debilitating pulmonary disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No allergy to egg or egg products

• No history of allergic reactions attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)

• No active or ongoing infection requiring IV antibiotics

• No psychiatric illness or social situation that would preclude study compliance

• No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No more than 1 prior cytokine-based regimen

• No concurrent biologic therapy

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• More than 4 weeks since prior major surgery

Other

• Recovered from prior therapy

• No more than 1 prior non-cytokine-based regimen

• No other prior systemic treatment regimens

• No other concurrent cytotoxic therapy

• No other concurrent anticancer therapy

• No other concurrent investigational agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center
• National Cancer Institute (NCI)

Investigators

• Study Chair: Gnanamba V. Kondagunta, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00093405
• Other Study ID Numbers: CDR0000387952; MSKCC-04082; NCI-6479
• First Posted: Oct 8, 2004
• Last Update Posted: Jun 24, 2013
• Last Verified: Nov 1, 2005

• Keywords provided by , ,: recurrent renal cell cancer; stage IV renal cell cancer; clear cell renal cell carcinoma
• Additional relevant MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell

Study Results

No Results Posted as of Jun 24, 2013