A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG)In Metastatic Renal Cell Carcinoma
18 Years
N/A
Both
Kidney Cancer
Trial Information
A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG)In Metastatic Renal Cell Carcinoma
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).
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy (complete and partial response)
Safety Issue:
No
Principal Investigator
Gnanamba V. Kondagunta, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000387952
NCT ID:
NCT00093405
Start Date:
August 2004
Completion Date:
November 2005
Related Keywords:
- Kidney Cancer
- recurrent renal cell cancer
- stage IV renal cell cancer
- clear cell renal cell carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
