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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: | NCT00004065 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid tumors or hematologic cancers.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer Breast Cancer Colorectal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Lung Cancer Melanoma (Skin) Ovarian Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: tanespimycin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC #330507) Daily X 5 in Patients With Advanced Cancer Therapeutic Protocol |
Study Start Date: | July 1999 |
OBJECTIVES:
OUTLINE: This is a two-phase, dose-escalation, multicenter study. Patients are stratified according to disease (chronic myelogenous leukemia [CML] or Philadelphia chromosome [Ph]+ acute lymphoblastic leukemia [ALL] vs solid tumor).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-90 minutes twice weekly. Courses repeat every 12 weeks in the absence of disease progression (after at least 2 courses for CML or Ph+ ALL patients) or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically confirmed advanced primary or malignant solid tumor refractory to standard therapy or for which no curative standard therapy exists
Progressive disease evidenced by 1 of the following:
Non-prostate cancer (including, but not limited to, breast, ovary, head and neck, non-small cell lung, bladder, kidney, colon, stomach, or malignant melanoma)
Prostate cancer (androgen independent) meeting the following criteria:
Metastatic disease and rising prostate-specific antigen (PSA) values meeting 1 of the following criteria:
Cytologically confirmed chronic, accelerated, or blastic phase chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) refractory to standard therapy or for which no curative therapy exists
Progressive disease evidenced by 1 of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No reversible defect by thallium stress test if any of the following conditions are present:
Patients with the following history or clinical findings require additional diagnostic testing:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Howard I. Scher, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067267, MSKCC-99037, NCI-T99-0035, UCLA-0206019 |
Study First Received: | December 10, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004065 |
Health Authority: | United States: Federal Government |
stage III colon cancer stage IV colon cancer stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage III gastric cancer stage IV gastric cancer recurrent gastric cancer stage IIIB breast cancer stage IIIC breast cancer recurrent non-small cell lung cancer recurrent colon cancer stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia stage III bladder cancer recurrent bladder cancer stage IV bladder cancer stage III prostate cancer stage IV prostate cancer recurrent prostate cancer stage III melanoma stage IV melanoma recurrent melanoma stage IIIA non-small cell lung cancer |
Thoracic Neoplasms Blast Crisis Chronic myelogenous leukemia Prostatic Diseases Malignant mesenchymal tumor Colonic Diseases Urogenital Neoplasms Ovarian epithelial cancer Urologic Neoplasms Rectal Diseases Carcinoma, Adenoid Cystic Lung Neoplasms Metastatic squamous neck cancer with occult primary Neuroepithelioma Laryngeal carcinoma |
Kidney Diseases Salivary Gland Diseases Breast Diseases Endocrine Gland Neoplasms Non-small cell lung cancer Precursor Cell Lymphoblastic Leukemia-Lymphoma Digestive System Neoplasms Urinary Bladder Diseases Genital Neoplasms, Female Urinary Bladder Neoplasms Endocrine System Diseases Breast Neoplasms Stomach cancer Carcinoma, Basal Cell Renal cancer |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site |
Neoplasms, Nerve Tissue Nevi and Melanomas Adnexal Diseases |