A Phase 1 interventional study of entinostat and isotretinoin in Adult Grade III Lymphomatoid Granulomatosis, Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-24.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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. 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
PRIMARY OBJECTIVES:
I. Determine the dose-limiting toxicity and maximum tolerated dose of MS-275 when administered with isotretinoin in patients with metastatic, progressive, refractory, or unresectable solid tumors or lymphomas.
SECONDARY OBJECTIVES:
I. Determine, preliminarily, tumor response in patients treated with this regimen.
II. Determine the pharmacokinetic profile of this regimen in these patients.
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.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 24 is below the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Histologically confirmed solid tumor or lymphoma
No prior oral isotretinoin
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.
Drug: entinostat · Drug: isotretinoin
Given orally
Also known as: HDAC inhibitor SNDX-275, SNDX-275
Given orally
Also known as: 13-CRA, Amnesteem, Cistane, Claravis, Sotret
Dose limiting toxicities defined as an adverse event which is likely related to the study medication
Graded using the CTCAE version 3.0.
Time frame: 28 days
Maximum tolerated dose of entinostat and isotretinoin in combination
Time frame: 28 days
Pharmacokinetics
Time frame: Up to day 21 of course 2
Adverse events defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
Graded using the CTCAE version 3.0. Summarized by dose level.
Time frame: Up to 30 days after completion of study treatment
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)