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New treatment option for HNSCC
Official title Single-Center Eval of Clinical & Radiological Benefit AHCC in Combo W/ SOC Tx for HPV+ Pts W/ HNSCC
ClinicalTrials.gov ID: NCT06693323
What this study is testing
What is AHCC®capsules?
AHCC®capsules is an investigational medicine, being studied as a potential treatment for hnscc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join 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)
You likely can't join 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...
- 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
See the full eligibility 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:
- 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...
- 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...
- 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...
- 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
- Platelets ≥ 100,000/μL
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- AST or /ALT ≤ 3.0 × institutional ULN
- 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:
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.