Drug combo targets rare cancers in early trial
NCT ID NCT00336063
First seen Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times
Summary
This early-phase trial tests the combination of two drugs, vorinostat and azacitidine, in people with nasopharyngeal cancer or nasal NK-T cell lymphoma that has come back or spread. The main goal is to find the safest dose and see how the body responds. Only 18 participants are enrolled, so this is a small, preliminary study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vorinostat and azacitidine
- What this could lead to
- If it works, this could point toward a new drug combination for hard-to-treat nasopharyngeal cancer and NK-T cell lymphoma.
- What could go wrong
- This is a very early (Phase 1) trial with only 18 people, focused on finding a safe dose. It is not designed to prove the drugs shrink tumors or improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Mar 2006
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adult nasal type extranodal NK/T-cell lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong
-
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
-
National Cancer Center Hospital
Tokyo, 104 0045, Japan
-
National Cancer Centre Singapore
Singapore, 168583, Singapore
-
National University Hospital Singapore
Singapore, 119074, Singapore
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug cocktail aims to tackle rare blood cancer
- Immunotherapy plus chemo shows promise for Tough-to-Treat nasopharyngeal cancer
- Immunotherapy boost may improve outcomes in returning throat cancer
- New surgery technique could improve survival in recurrent throat cancer
- New Two-Step transplant shows promise for blood cancer patients
- Proton beam takes aim at returning throat cancer