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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00093405 |
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 | Intervention | Phase |
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Kidney Cancer |
Drug: tanespimycin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG)In Metastatic Renal Cell Carcinoma |
Study Start Date: | August 2004 |
OBJECTIVES:
Primary
Secondary
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
Papillary OR clear cell histology
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Gnanamba V. Kondagunta, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000387952, MSKCC-04082, NCI-6479 |
Study First Received: | October 6, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00093405 |
Health Authority: | United States: Federal Government |
recurrent renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |