RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Single-Center Evaluation of the Clinical and Radiological Benefit of AHCC® in Combination with Standard of Care Treatment for HPV-Positive Patients with Head and Neck Squamous Cell Carcinoma (HNSCC)

Quick Facts

Study Start:2024-12-04

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06693323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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: 1. Positive Margins and/or Extra Nodal Extension (ENE) 2. 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 3. 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. 1. 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: 1. Absolute neutrophil count (ANC) ≥ 1,500/μL 2. Platelets ≥ 100,000/μL 3. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) 4. AST or /ALT ≤ 3.0 × institutional ULN 5. Creatinine clearance \> 30 mL/min using the Cockcroft-Gault formula	* 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: 1. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) 2. systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent 3. 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. 1. 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. 2. 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. 3. 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 1. detectable viral loads within 6 months, or 2. history of Kaposi sarcoma and/or Multicentric Castleman Disease. * Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Known allergy to mushrooms, mushroom products, or any components of the study formulation. * Known psychiatric or substance abuse disorder that would interfere with the participant's ability to complete study assessments or to adhere to protocol requirements.

Inclusion Criteria

Exclusion Criteria

* 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:
1. Positive Margins and/or Extra Nodal Extension (ENE)
2. 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
3. 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.
1. 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:
1. Absolute neutrophil count (ANC) ≥ 1,500/μL
2. Platelets ≥ 100,000/μL
3. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
4. AST or /ALT ≤ 3.0 × institutional ULN
5. Creatinine clearance \> 30 mL/min using the Cockcroft-Gault formula

* 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:
1. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
2. systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
3. 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.
1. 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.
2. 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.
3. 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
1. detectable viral loads within 6 months, or
2. history of Kaposi sarcoma and/or Multicentric Castleman Disease.
* Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
* Known allergy to mushrooms, mushroom products, or any components of the study formulation.
* Known psychiatric or substance abuse disorder that would interfere with the participant's ability to complete study assessments or to adhere to protocol requirements.

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Principal Investigator

Rupali Nabar, MD

PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Rupali Nabar, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-12-04

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

HNSCC
Head and Neck Squamous Cell Carcinoma