AHCC Capsules for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byRupali Nabar

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of California, Irvine

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a phase 2, single-arm, open-label clinical trial determining safety and tolerability of AHCC in subjects with HPV-positive patients with Head and Neck Squamous Cell Carcinoma. These are subjects who have undergone surgery or will be undergoing surgery.

Eligibility Criteria

Adults aged 18-79 with HPV-positive Head and Neck Squamous Cell Carcinoma (HNSCC) who've had or will have surgery. They must be at high risk for disease recurrence, not pregnant, willing to use contraception, and free from serious infections, autoimmune diseases treated within the last 2 years, organ transplants, certain heart conditions, HIV with detectable viral load or history of specific diseases.

Inclusion Criteria

I am between 18 and 79 years old.

I had surgery at least 4 weeks ago.

For patients that have completed surgery, has a high risk disease defined as: Positive Margins and/or Extra Nodal Extension (ENE), No evidence of distant disease based on baseline imaging done within 28 days prior to registration, Has an ECOG Performance Status 0-1, Has the ability to understand and the willingness to sign a written informed consent document, All females of childbearing potential must have a blood test or urine study within 14 days prior to registration negative for pregnancy, Women of childbearing potential and sexually active males must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on study treatment, and continue for 120 days after the last dose of study treatment, Has adequate organ and marrow function as defined below, based on clinical laboratory assessments obtained ≤ 28 days prior to registration

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Exclusion Criteria

I am not currently being treated for an infection.

Known psychiatric or substance abuse disorder that would interfere with the participant's ability to complete study assessments or to adhere to protocol requirements

I have not taken immunosuppressive medication in the last 7 days.

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Treatment Details

Interventions

AHCC (Cancer Vaccine)

Trial OverviewThe trial is testing AHCC® capsules' safety and tolerability in HPV-positive HNSCC patients post-surgery. It's a phase 2 study where all participants receive the same treatment without a comparison group.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: AHCCExperimental Treatment1 Intervention

Oral Drug

AHCC is already approved in Japan, United States for the following indications:

🇯🇵 Approved in Japan as AHCC for: