Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma
Adult Nasal Type Extranodal NK/T-Cell Lymphoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Nasopharyngeal Undifferentiated Carcinoma
About this trial
This is an interventional treatment trial for Adult Nasal Type Extranodal NK/T-Cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Biopsy proven nasopharyngeal carcinoma (World Health Organization [WHO] type 3) or extranodal NK-T-cell non-Hodgkin's lymphoma, nasal type (recurrence or metastases does not require tissue documentation) Patients must have metastatic disease or locally recurrent disease that is not amendable to surgical resection Patients must have locally recurrent disease that is not amendable to further treatment with radiotherapy with curative intent Patients must have metastatic disease or locally recurrent disease that has been treated with at least one regimen of chemotherapeutic agents after relapse; patient must be at least 4 weeks since prior chemotherapy or radiation therapy Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Life expectancy greater than 6 months Leukocytes >= 3,000/ul Absolute neutrophil count >= 1,500/ul Platelets >= 100,000/ul Total bilirubin =< 1.5 X normal institutional limits Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal Prothrombin time =< 1.5 X normal institutional limits Serum albumin >= 2.7 grams/deciliter Creatinine =< 1.5 X normal institutional limits or a calculated creatinine clearance of > 50 mls/min Sexually active women of child-bearing potential should have a negative serum or urine pregnancy test within 21 days of enrolling on trial; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Patients must be informed of the investigational nature of the treatment, results that might be expected, and potential toxicities; they must be able to give informed written consent according to federal and institutional guidelines Exclusion Criteria: Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Patients may not be receiving any other investigational agents Patients with known central nervous system (CNS) involvement (brain metastases or carcinomatous meningitis should be excluded from this clinical trial; patients with skull base involvement are eligible for this study History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5AC or SAHA Patients should not have taken sodium valproate for at least 2 weeks prior to enrollment Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with 5AC and SAHA Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study Patients with chronic active hepatitis B are excluded from the study
Sites / Locations
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Chinese University of Hong Kong-Prince of Wales Hospital
- National Cancer Center Hospital
- National University Hospital Singapore
- National Cancer Centre Singapore
- Johns Hopkins Singapore
Arms of the Study
Arm 1
Experimental
Treatment (azacitidine, vorinostat)
Patients receive azacitidine SC on days 1-10 and vorinostat PO BID on days 1-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.