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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020579 |
RATIONALE: MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 in treating patients with advanced solid tumors or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: entinostat |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of an Oral Histone Deacetylase Inhibitor, MS-275, in Refractory Solid Tumors and Lymphomas |
Estimated Enrollment: | 75 |
Study Start Date: | March 2001 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study.
Patients receive oral MS-275 once on day 1. Courses repeat every 2 weeks (every 2-week schedule). Alternatively, patients receive oral MS-275 once on days 1, 8, 15, and 22 (weekly schedule). Courses repeat every 6 weeks.
Treatment for both schedules continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of MS-275 on the every 2-week schedule until the maximum tolerated dose (MTD) is determined. Once the MTD for the every 2-week schedule is determined, patients receive treatment on the weekly schedule as above. The MTD is then determined for the weekly schedule. The MTD for both schedules is defined as the dose preceding that at which at least 2 of up to 6 patients experience dose-limiting toxicity. Once the MTD is determined for the weekly schedule, up to 3 additional patients are accrued to receive MS-275 at the MTD of the weekly schedule.
Disease status is assessed every 3 months.
PROJECTED ACCRUAL: A total of 50-75 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:
Brain metastases allowed provided both of the following criteria are met:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Concurrent corticosteroids for physiological replacement, as antiemetic therapy, or for an ongoing condition allowed
Radiotherapy:
No concurrent radiotherapy
Surgery:
Other:
United States, Maryland | |
National Naval Medical Center | |
Bethesda, Maryland, United States, 20889-5000 | |
NCI - Center for Cancer Research | |
Bethesda, Maryland, United States, 20892 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Shivaani Kummar, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000068615, NCI-01-C-0124, NCI-2792 |
Study First Received: | July 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00020579 History of Changes |
Health Authority: | United States: Federal Government |
stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma small intestine lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma primary central nervous system lymphoma intraocular lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma stage IV mycosis fungoides/Sezary syndrome |
Mantle Cell Lymphoma Lung Neoplasms Wilms' Tumor Lymphoma, Large-Cell, Anaplastic Neuroepithelioma Vaginal Neoplasms Nasopharyngeal Carcinoma Testicular Cancer Astrocytoma Breast Neoplasms Testicular Neoplasms Aggressive Fibromatosis Ewing's Sarcoma Carcinoma Brain Neoplasms |
Uterine Sarcoma Sarcoma Gallbladder Neoplasms Esophageal Diseases Stomach Cancer Lymphoma, Non-Hodgkin Carcinoma, Non-Small-Cell Lung Anus Neoplasms Choroid Plexus Neoplasms Fallopian Tube Cancer Uveal Melanoma Laryngeal Carcinoma Desmoid Tumor Vulvar Cancer Melanoma of the Choroid |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma |