MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Head and Neck Squamous Cell Carcinoma, Oral Mucositis
In brief
The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT).
Key facts
- Study ID
- NCT04651634
- Run by
- MitoImmune Therapeutics
- People needed
- 60
- Starts
- 2021-06-21
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-04-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed HNSCC (The American joint committee on cancer [AJCC] 8th edition, Stage II, III, IVA, or IVB), involving either the oral cavity or oropharynx, or HPV-positive Stage I oropharyngeal cancer.
- Treatment plan to receive a continuous course of intensity-modulated radiation therapy (IMRT) for definitive treatment of HNSCC delivered as single daily fractions of 1.8 to 2.5 Gy with a cumulative radiation dose between 60 and 72 Gy (EQD2 of 60 to 72 Gy, α/β ratio=10): Planned radiation treatment fields must include at least 30% of oral cavity that are planned to receive a total of 50 Gy or higher.
- CCRT plan to receive standard cisplatin monotherapy: Standard cisplatin monotherapy administered weekly (30 to 40 mg/m2), once per week for 5 to 7 continuous weeks.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less
- Serum pregnancy test negative for women of childbearing potential (woman of childbearing potential [WOCBP]
You may not qualify if…
- Patients who have active mucositis at screening.
- Planned to receive Erbitux™ (Cetuximab) or other targeted or immune therapy during the study.
- Tumor of the lips, sinuses, or salivary glands or unknown primary tumors.
- Metastatic disease (M1) Stage.
- Known history of severe vascular toxicity or allergies or intolerance to cisplatin and similar platinum-containing compounds.
- Any clinically significant and/or active infection, other systemic illness or condition (other than HNSCC) that would preclude them from participating in the study in the opinion of the Investigator.
- Prior resective surgery (4 weeks or less than 4 weeks from receiving surgery to randomization) for primary tumor under treatment for HNSCC.
Where it is running
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
- Norris Comprehensive Cancer Center — Los Angeles, California, United States
- Cancer Center of Kansas — Wichita, Kansas, United States
- James P. Wilmot Cancer Center — Rochester, New York, United States
- Wake Forest Baptist Health - Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
- James Cancer Hospital Solove Research Institute — Columbus, Ohio, United States
- The Catholic University of Korea Saint Vincent's Hospital — Suwon, Gyeonggi-do, South Korea
- Jeonbuk National University Hospital — Jeonju, Jeollabuk-do, South Korea
- Keimyung University Dongsan Hospital — Daegu, South Korea
- Chungnam National University Hospital — Daejeon, South Korea
- National Cancer Center — Goyang-si, South Korea
- Seoul National University Bundang Hospital — Gyeonggi-do, South Korea
- Inha University Hospital — Incheon, South Korea
- Seoul National University Hospital — Seoul, South Korea
- Korea University Guro Hospital — Seoul, South Korea
- Hanyang University Seoul Hospital — Seoul, South Korea
Full record on ClinicalTrials.gov
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