此第一期试验研究 vorinostat 与 azacitidine 联合使用时的不良反应及最佳剂量，用于治疗鼻咽癌或鼻腔自然杀手T细胞淋巴瘤，该癌症已在原发（主要）肿瘤同一位置或附近复发（再次出现），通常是在一段无法检测到癌症的时期之后，或已扩散至身体其他部位。
适应症：Adult Nasal Type Extranodal NK/T-Cell Lymphoma、Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma、Recurrent Nasopharyngeal Undifferentiated Carcinoma、Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7、Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7
入组条件
纳入标准
- 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
排除标准
- 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
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。