Status:
ACTIVE_NOT_RECRUITING
Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Nasal Type Extranodal NK/T-Cell Lymphoma
Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of vorinostat when given together with azacitidine in treating patients with nasopharyngeal cancer or nasal natural killer T-cell lymphoma tha...
Detailed Description
PRIMARY OBJECTIVES: I. Define toxicity profile of escalating doses of suberoylanilide hydroxamic acid (SAHA) given in conjunction with a fixed dose of 5 Azacytidine (5AC) (azacitidine) in patients wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00336063
Start Date
March 3 2006
End Date
March 19 2026
Last Update
August 20 2025
Active Locations (5)
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1
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
2
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong
3
National Cancer Center Hospital
Tokyo, Japan, 104 0045
4
National University Hospital Singapore
Singapore, Singapore, 119074