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| Descriptive Information Fields | |||||
| Brief Title † | MS-275 in Treating Patients With Advanced Solid Tumors or Lymphoma | ||||
| Official Title † | A Phase I Study of an Oral Histone Deacetylase Inhibitor, MS-275, in Refractory Solid Tumors and Lymphomas | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Dose-limiting toxicities and maximum tolerated dose [ Designated as safety issue: Yes ] Pharmacology and pharmacokinetics [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Acetylation of histones in peripheral blood [ Designated as safety issue: No ] Tumor response by CT scan every 12 weeks [ Designated as safety issue: No ] |
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| Condition † | Cancer | ||||
| Intervention † | Drug: HDAC inhibitor SNDX-275 | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 75 | ||||
| Start Date † | March 2001 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00020579 | ||||
| Organization ID | CDR0000068615 | ||||
| Secondary IDs †† | NCI-01-C-0124, NCI-2792 | ||||
| Study Sponsor † | National Cancer Institute (NCI) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2007 | ||||
| First Received Date † | July 11, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||