Status:
COMPLETED
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-demeth...
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00093405
Start Date
August 1 2004
End Date
November 1 2005
Last Update
June 24 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021