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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: | NCT00087386 |
RATIONALE: Antitumor antibiotics such as 17-N-allylamino-17-demethoxygeldanamycin may stop the growth of melanoma by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with stage III or stage IV melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: tanespimycin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC #330507) Diluted In EPL Diluent (NSC #704057) In Metastatic Melanoma Patients |
Estimated Enrollment: | 50 |
Study Start Date: | June 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF mutation in tumor (yes vs no).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study within 1.5-2.5 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma
Measurable disease
Tumor amenable to biopsy (for the first 10 patients in each stratum only)
No brain or epidural metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 1 prior chemotherapy regimen for metastatic melanoma
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent treatment with any of the following medications or herbal remedies:
Inhibitors of CYP3A4:
Inducers of CYP3A4:
Herbal extracts and tinctures with CYP3A4 inhibitory activity:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
NYU Cancer Institute at New York University Medical Center | |
New York, New York, United States, 10016 |
Study Chair: | Paul B. Chapman, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000374980, MSKCC-04056, NCI-6480 |
Study First Received: | July 8, 2004 |
Last Updated: | June 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00087386 |
Health Authority: | United States: Federal Government |
stage III melanoma stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |