Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC

NCT06693323 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 5821UCI 21-173
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HNSCC; Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC; Head and Neck Squamous Cell Carcinoma; AHCC; HPV-Positive HNSCC

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) of Patients receiving AHCC and concurrent standard of care treatment regimens

  To evaluate the overall survival of patients with HPV-positive Head and Heck squamous cell carcinoma

  60 months

Secondary Outcomes (2)

• Difference in Tumor Response of patients receiving concurrent therapy with chemoradiation plus AHCC over SoC treatment and in the long term follow up period compared to historical data.

  5 years

• Percentage of Adverse Events

  Up to 24 cycles

Other Outcomes (2)

• Change in Quality of Life (QoL) score

  At the end of Cycle 6 (each cycle is 28 days)

• Changes in HPV DNA in blood samples from HPV+ patients with HNSCC

  Up to 5 years

Study Arms (1)

AHCC

EXPERIMENTAL

Oral Drug

Drug: AHCC®capsules

Interventions

AHCC®capsules DRUG

Given PO

AHCC

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 79 years of age.
• Has a diagnosis of pathologically or cytologically proven HPV positive HNSCC.
• For patients who have undergone surgery, they must be registered at least 4 weeks after surgery.
• For patients that have completed surgery, has a high risk disease defined as:
• Positive Margins and/or Extra Nodal Extension (ENE)
• Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e., carcinoma in situ) at the margin is also considered positive
• ENE may be either gross or microscopic
• No evidence of distant disease based on baseline imaging done within 28 days prior to registration. Patient may be any T or N stage, but must be M0
• Has an ECOG Performance Status 0-1.
• Has the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
• All females of childbearing potential must have a blood test or urine study within 14 days prior to registration negative for pregnancy.
• \. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets any of the following criteria: has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
• 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. Accepted and effective methods are described in Appendix 4
• Has adequate organ and marrow function as defined below, based on clinical laboratory assessments obtained ≤ 28 days prior to registration:
• Absolute neutrophil count (ANC) ≥ 1,500/μL

You may not qualify if:

• Patient must not be pregnant or breast-feeding due to the unknown potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
• Current active infection that requires systemic treatment at time of registration.
• History of solid organ transplant or stem cell transplant.
• Currently taking immunosuppressive medication within 7 days prior to registration, EXCEPT for the following:
• intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
• systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
• steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
• New York Heart Association Class III or IV heart failure. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
• Received a live vaccine within 30 days prior to the first dose of study drug.
• Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), or typhoid fever.
• Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
• COVID-19 (SARS-CoV-2) vaccines (mRNA or other) are allowed.
• Known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as positive for HCV RNA on a qualitative test).
• History of HIV with or without antiviral treatment having
• detectable viral loads within 6 months, or

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Rupali Nabar, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

US (1)