Expired Study
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Baltimore, Maryland 21287


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. 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


Study summary:

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.


Criteria:

Inclusion Criteria: - Histologically confirmed solid tumor or lymphoma - Metastatic, progressive, refractory, or unresectable disease - Not amenable to standard curative measures - No known brain metastases - Performance status - ECOG 0-2 - More than 3 months - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - WBC ≥ 3,000/mm^3 - Hemoglobin > 9 g/dL - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 2.5 times ULN - No suspected Gilbert's syndrome - Creatinine ≤ 1.5 times ULN - Creatinine clearance ≥ 60 mL/min - No symptomatic congestive heart failure - No unstable angina pectoris - No unstable cardiac arryhthmia - Able to take and retain oral medications - No malabsorption problems - No acute or chronic gastrointestinal condition - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-method contraception 1 month before, during, and 3 months after study treatment - No known HIV positivity - No weight loss > 10% within the past 2 months - No history of allergic reaction attributed to compounds of similar chemical or biologic composition to MS-275 or isotretinoin - No other uncontrolled illness - No ongoing or active infection - No seizure disorder - No psychiatric illness or social situation that would preclude study participation - More than 4 weeks since prior anticancer vaccine therapy - More than 4 weeks since prior anticancer immunotherapy - No concurrent anticancer vaccine therapy - No concurrent anticancer immunotherapy - More than 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas, mitomycin, or other agents known to cause prolonged marrow supression) - No concurrent anticancer chemotherapy - More than 4 weeks since prior anticancer hormonal therapy except gonadotropin-releasing hormone (GnRH) agonist therapy for non-castrated patients with prostate cancer - Concurrent GnRH agonist therapy for non-castrated patients with prostate cancer allowed - Concurrent luteinizing hormone-releasing hormone agonist therapy allowed provided there is evidence of tumor progression - Concurrent adrenal steroid replacement therapy allowed - No concurrent ketoconazole as second-line hormonal treatment for prostate cancer - No concurrent corticosteroids except for treatment of refractory nausea or vomiting - No other concurrent anticancer hormonal therapy - More than 4 weeks since prior anticancer radiotherapy - More than 2 weeks since prior palliative radiotherapy - No concurrent anticancer radiotherapy - More than 4 weeks since prior major surgery - Recovered from all prior therapy - No prior MS-275 - No prior oral isotretinoin - Isotretinoin for the treatment of acne allowed provided > 3 years since prior administration - More than 4 weeks since other prior anticancer therapy - No concurrent tetracycline - No concurrent high-dose vitamin A - No concurrent valproic acid - No other concurrent investigational agents - No other concurrent anticancer therapy


NCT ID:

NCT00098891


Primary Contact:

Principal Investigator
Roberto Pili
Johns Hopkins University


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21287
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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