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Nucleoside Metabolic Inhibitor
Vorinostat + Azacitidine for Head and Neck Cancers
Phase 1
Waitlist Available
Led By Wen-Son Hsieh
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have locally recurrent disease that is not amendable to further treatment with radiotherapy with curative intent
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial is studying vorinostat and azacitidine to see how well they work in treating patients with nasopharyngeal cancer or nasal natural killer T-cell lymphoma.
Who is the study for?
This trial is for adults with nasopharyngeal cancer or nasal natural killer T-cell lymphoma that has returned or spread, who have already tried at least one chemotherapy treatment. They must be in good enough health to participate, not pregnant, willing to use contraception, and not have any serious illnesses that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing the combination of two chemotherapy drugs, Vorinostat and Azacitidine. It aims to find the safest doses and see how well they work together against recurrent or metastatic nasopharyngeal cancer or nasal NK T-cell lymphoma by blocking enzymes needed for cell growth.See study design
What are the potential side effects?
Possible side effects from Vorinostat and Azacitidine may include nausea, vomiting, diarrhea, fatigue, low blood counts leading to increased infection risk or bleeding problems. There might also be liver function changes and reactions related to drug infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has come back in the same area but cannot be treated with radiation to cure it.
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function, measured by creatinine levels, is within normal limits.
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I have been diagnosed with a specific type of throat or nasal cancer.
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My cancer has spread and cannot be removed with surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of vorinostat and azacitidine, defined as the dose at which less than one-third of patients experience a dose limiting toxicity (i.e., fewer than 2 of 6 patients)
Precision of the estimated dose-response curve based on induction of lytically replicated viral particles in the plasma following treatment
Secondary outcome measures
EBV promoter demethylation as measured in tumor patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell nasal lymphoma
Pharmacokinetics of vorinostat in patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell nasal lymphoma
Proportions of patients with high and low histone acetylation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (azacitidine, vorinostat)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1410
Vorinostat
2014
Completed Phase 3
~1600
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,346 Total Patients Enrolled
1 Trials studying Nasopharyngeal Undifferentiated Carcinoma
818 Patients Enrolled for Nasopharyngeal Undifferentiated Carcinoma
Wen-Son HsiehPrincipal InvestigatorJohns Hopkins Singapore
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has come back in the same area but cannot be treated with radiation to cure it.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have cancer that has spread or returned and was treated with chemotherapy after it came back.I can take care of myself but might not be able to do heavy physical work.I do not have chronic active hepatitis B.I am not pregnant and will use birth control during the study.I haven't taken sodium valproate in the last 2 weeks.My kidney function, measured by creatinine levels, is within normal limits.You are expected to live for at least 6 more months.I have been diagnosed with a specific type of throat or nasal cancer.My cancer has spread and cannot be removed with surgery.I am not HIV-positive or not on anti-retroviral therapy.You have had allergic reactions to drugs that are similar to 5AC or SAHA.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.I do not have cancer spread to my brain or its coverings but may have it at the base of my skull.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (azacitidine, vorinostat)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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