← Back to Search

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%)

Must not have

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

Patients with chronic active hepatitis B are excluded from the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

My cancer has come back in the same area but cannot be treated with radiation to cure it.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My kidney function, measured by creatinine levels, is within normal limits.

Select...

I have been diagnosed with a specific type of throat or nasal cancer.

Select...

My cancer has spread and cannot be removed with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

I do not have chronic active hepatitis B.

Select...

I am not HIV-positive or not on anti-retroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1440

Vorinostat

2014

Completed Phase 3

~1600