MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas
Adult Grade III Lymphomatoid Granulomatosis, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
About this trial
This is an interventional treatment trial for Adult Grade III Lymphomatoid Granulomatosis
Eligibility 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
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Experimental
Treatment (entinostat, 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.