Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10021


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.

Study summary:

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).


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



Primary Contact:

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

Backup Contact:


Location Contact:

New York, New York 10021
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.