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Sponsored by: |
National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00088868 |
RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with an advanced solid tumor or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: alvespimycin hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin (17DMAG) With Evaluation Of Hsp90 Client Proteins In Subjects With Solid Tumors And Lymphomas |
Estimated Enrollment: | 40 |
Study Start Date: | June 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a single-center, dose-escalation study.
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-2 hour on days 1 and 4 or days 2 and 5 weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of 17-DMAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at the MTD.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant solid tumor OR lymphoma
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No uncontrolled symptomatic pulmonary disease, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Shivaani Kummar, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000377488, NCI-04-C-0218, NCI-6544 |
Study First Received: | August 4, 2004 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00088868 |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific anaplastic large cell lymphoma intraocular lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma |
stage III adult lymphoblastic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III small lymphocytic lymphoma stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Hodgkin lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma |
Sezary syndrome Lymphoma, Mantle-Cell Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Ileal Diseases Lymphoma, large-cell, immunoblastic Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Digestive System Neoplasms |
Leukemia, B-cell, chronic Waldenstrom Macroglobulinemia B-cell lymphomas Leukemia, T-Cell Gastrointestinal Neoplasms Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Hodgkin's disease Gastrointestinal Diseases Cutaneous T-cell lymphoma Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Sezary Syndrome Mycosis Fungoides |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immune System Diseases Jejunal Diseases |