A Phase 2, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of MIT-001 in Prevention of Oral Mucositis in Patients Receiving CCRT for Locally Advanced HNSCC
Description
Brief Summary
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).
Detailed Description
Oral mucositis associated with cancer therapy carries a significant morbidity. OM is a common
complication in patients receiving CCRT used for treating HNSCC. Mucositis lesions can be
painful, affect nutrition and quality of life (QoL), and have a significant economic impact.
However, a definitive intervention regime has not been established. Therefore, it is
essential to develop appropriate treatment.
MitoImmune Therapeutics Inc. (hereafter referred to as Sponsor) has developed MIT-001 which
can scavenge abnormal levels of reactive oxygen species (ROS), enabling the cells to retain
mitochondrial membrane permeability and mitochondrial function. This eventually inhibits
additional ROS production, indicating that MIT-001 can prevent excessive inflammation caused
by ROS. In addition, MIT-001 may possibly 1) block inflammatory cytokine production via
inhibiting nuclear factor kappa B (NF kB) or inflammasome dependent pathways, 2) inhibit
necrosis/necroptosis via blocking high mobility group box 1 (HMGB1) mediated cytokine
production, and 3) balance regulation between T helper type 1/17 (Th1/17) and regulatory T
cells.
Based on the pathophysiological progression of CCRT-associated OM, initiated by direct injury
to basal epithelial cells which experience deoxyribonucleic acid (DNA) damage and increased
ROS levels, Sponsor expects the prevention of OM in patients receiving CCRT of locally
advanced HNSCC with MIT 001 by effectively scavenging increased ROS induced by CCRT.
Phase
N/AInclusion and Exclusion Criteria
- Inclusion Criteria:
- 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] Exclusion Criteria:
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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