Birinapant + IMRRT for Head and Neck Cancer

Recruiting at33 trial locations

Overseen by Vassiliki Saloura

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of birinapant when given together with intensity modulated re-irradiation therapy (IMRRT) in treating patients with head and neck squamous cell carcinoma that has come back at or near the same place as the original (primary) tumor (locally recurrent). Birinapant may stop the growth of tumor cells by blocking inhibitor of apoptosis (IAP), a protein needed for tumor cell survival. IMRRT uses thin beams of radiation of different intensities that are aimed at the tumor from many angles. This type of re-irradiation therapy reduces the damage to healthy tissue near the tumor. Giving birinapant with IMRRT may lower the chance of head and neck squamous cell carcinoma growing or spreading.

Research Team

Vassiliki Saloura

Principal Investigator

National Cancer Institute LAO

Eligibility Criteria

This trial is for adults with locally recurrent head and neck squamous cell carcinoma, including nasopharyngeal or sinonasal cancer. Candidates must have previously undergone platinum- or cetuximab-based therapy, be at least 4 weeks post chemotherapy/immunotherapy, and at least 6 months post radiotherapy. They should not have had more than two lines of systemic therapy and must not be HIV positive on antiretroviral therapy.

Inclusion Criteria

Serum creatinine =< 1.5 x upper limit of normal (ULN), OR: Creatinine clearance >= 50 mL/min according to Cockcroft Gault formula or other institutional methods

Ability to understand and the willingness to sign a written informed consent document

Patients must have a corrected QT interval by Fridericia (QTcF) =< 480 msec

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to birinapant

Patients with previous exposure to birinapant

Human immunodeficiency virus (HIV) positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with birinapant

Treatment Details

Interventions

• Birinapant (IAP Antagonist)
• Intensity-Modulated Radiation Therapy (Radiation)

Trial Overview The trial tests birinapant in combination with intensity-modulated re-irradiation therapy (IMRRT) to treat recurring head and neck cancer. Birinapant aims to block proteins that tumor cells need to survive while IMRRT targets the tumor with precision to minimize damage to healthy tissue.

Participant Groups

Group I: Treatment (intensity modulated re-irradiation therapy (IMRRT), birinapant) Experimental Treatment 6 Interventions

Beginning on day 1, patients undergo intensity modulated re-irradiation therapy (IMRRT) 5 days a week (Monday-Friday). Participants also receive birinapant intravenous (IV) over 30 minutes on days 2 and 9 of each cycle. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School