Clinical trial for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Official title Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
ClinicalTrials.gov ID: NCT06532279
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, being studied as a potential treatment for clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Also referred to as Abiplatin, Blastolem.
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
- The study wants to see whether BMX-001 reduces oral mucositis (painful mouth sores) compared with usual symptom management alone.
- Who it's for
- People with head or neck cancer who are receiving chemoradiation therapy.
- What's involved
- Participants receive either BMX-001 or a placebo, plus the usual mouth rinses and pain medicines, and will have regular oral exams and safety checks.
- Time commitment
- The trial runs through the course of chemoradiation and a few weeks afterward, with multiple clinic visits during treatment.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy.
- At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least...
- Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral...
- P16 and/or human papillomavirus (HPV) status (via polymerase chain reaction [PCR] or in situ hybridization [ISH]) must be documented for patients...
- No patients with T0/Tx/unknown primary disease.
See the full eligibility criteria
Who can join
- Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.
- At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \>= 50 Gy.
- Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
- P16 and/or human papillomavirus (HPV) status (via polymerase chain reaction [PCR] or in situ hybridization [ISH]) must be documented for patients with oropharynx cancer.
- No patients with T0/Tx/unknown primary disease.
- No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.
- Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.
- Age \>= 18.
- Zubrod performance status of 0-2.
- Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.
- Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3.
- Platelets \>= 100,000 cells/mm\^3.
- Hemoglobin \>= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] \>= 10.0 g/dl is acceptable).
- Adequate renal function defined as creatinine clearance (CrCL) \> 50 mL/min by the Cockcroft-Gault formula.
- Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 x institutional ULN.
- No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa/level 4 neck.
- No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
- No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident...
- No current treatment of adjuvant post-operative (op) chemoradiation.
- No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\< 4 days before registration.
- No prior induction chemotherapy treatment.
- No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low...
- No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.
- No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment
- No valvular heart disease.
- No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.
- No history or evidence upon physical/neurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.
- No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.
- No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.
- No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT/corrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms [EKGs] in prior 3 months of a QTc interval \> 450 milliseconds...
- Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.
- No poorly controlled hypertension (systolic blood pressure [SBP] \> 160 and/or diastolic blood pressure [DBP] \> 95) over 2 repeated measures within 30 days prior to registration.
- No grade \>= 2 oral mucositis per CTCAE version 5.0.
- No grade \>= 2 hypotension per CTCAE v. 5.0.
- No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics.
- No medical necessity for medications listed as prohibited.
- For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Clinical Practice Guidelines for the...
- LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a...
- No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
- Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Peoria, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Surprise, Arizona, United States
- Tempe, Arizona, United States
- Jonesboro, Arkansas, United States
- Encinitas, California, United States
- La Jolla, California, United States
- San Diego, California, United States
- Edwards, Colorado, United States
- Washington D.C., District of Columbia, United States
- N. Venice, Florida, United States
- Ruskin, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Venice, Florida, United States
- Wesley Chapel, Florida, United States
- Bloomington, Illinois, United States
- Canton, Illinois, United States
+ 103 more site(s).
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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Peoria, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Surprise, Arizona, United States; Tempe, Arizona, United States and 117 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.