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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098891 |
Purpose
RATIONALE: MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Isotretinoin may help cancer cells develop into normal cells. MS-275 may increase the effectiveness of isotretinoin by making cancer cells more sensitive to the drug. MS-275 and isotretinoin may also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer. Combining MS-275 with isotretinoin may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating patients who have metastatic or advanced solid tumors or lymphomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: entinostat Drug: isotretinoin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of an Oral Histone Deacetylase Inhibitor, MS-275 (NSC 706995, IND 61,196), in Combination With 13-Cis-Retinoic Acid in Metastatic Progressive Cancer |
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2004 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study of MS-275.
Patients receive oral MS-275 once on days 1, 8, and 15 and oral isotretinoin twice daily on days 1-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 12 patients are treated at the MTD.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor or lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No prior oral isotretinoin
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Roberto Pili, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00098891 History of Changes |
| Other Study ID Numbers: | CDR0000396776, JHOC-J0438, NCI-6798, JHOC-04060103 |
| Study First Received: | December 8, 2004 |
| Last Updated: | March 13, 2010 |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific primary central nervous system non-Hodgkin lymphoma intraocular lymphoma small intestine lymphoma recurrent adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
stage IV grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma recurrent mantle cell lymphoma stage IV mantle cell lymphoma recurrent marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma stage IV marginal zone lymphoma recurrent small lymphocytic lymphoma stage IV small lymphocytic lymphoma recurrent adult Burkitt lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma |
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Isotretinoin Histone Deacetylase Inhibitors Dermatologic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |