Expired Study
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New York, New York 10021


Purpose:

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).


Criteria:

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


NCT ID:

NCT00093405


Primary Contact:

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


Backup Contact:

N/A


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: December 15, 2017

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