RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
NCT ID: NCT05966194
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
216 participants
INTERVENTIONAL
2024-04-02
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
Pretreatment consists of 8 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period
RRx-001
RRx-001 for injection (4 mg or 8 mg)
Intensity Modulated Radiation Therapy (IMRT)
Intensity Modulated Radiation Therapy of up to 72 Gy
Cisplatin for injection 100 mg/m2
Cisplatin for injection 100 mg/m2
RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
Pretreatment consists of 4 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period.
RRx-001
RRx-001 for injection (4 mg or 8 mg)
Intensity Modulated Radiation Therapy (IMRT)
Intensity Modulated Radiation Therapy of up to 72 Gy
Cisplatin for injection 100 mg/m2
Cisplatin for injection 100 mg/m2
Placebo Pre-Treatment + Chemoradiation Therapy (CRT)
No doses of RRx-001 will be administered. Patients assigned to this arm will receive placebo twice weekly during the 2 weeks prior to the start of CRT followed by the CRT treatment period.
Intensity Modulated Radiation Therapy (IMRT)
Intensity Modulated Radiation Therapy of up to 72 Gy
Cisplatin for injection 100 mg/m2
Cisplatin for injection 100 mg/m2
Interventions
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RRx-001
RRx-001 for injection (4 mg or 8 mg)
Intensity Modulated Radiation Therapy (IMRT)
Intensity Modulated Radiation Therapy of up to 72 Gy
Cisplatin for injection 100 mg/m2
Cisplatin for injection 100 mg/m2
Eligibility Criteria
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Inclusion Criteria
2. Radiation Treatment planned to receive standard IMRT with daily fractions of 2.0 to 2.2 Gy for a total cumulative dose of 60-72 Gy in conjunction with definitive or adjuvant chemotherapy. Planned radiation treatment fields must include at least two oral sites (soft palate, floor of mouth, buccal mucosa, tongue) that are each planned to receive a total of \> 55 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
3. ECOG performance status ≤ 2.
4. Participants must have adequate organ and marrow function as defined below:
• Absolute neutrophil count (ANC) ≥ 1,500 / mm3 2. Platelets ≥ 75,000 / mm3 3. Hemoglobin ≥ 9.0 g/dL
5. Adequate renal and liver function as indicated by:
• Serum creatinine acceptable for treatment with cisplatin per institutional guidelines) 2. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 4. Alkaline phosphatase ≤ 2.5 x ULN
6. Human papilloma virus (HPV) status in tumor must be documented using tumor immunohistochemistry for HPV-p16 or other accepted test (such as such as in situ hybridization) for patients with cancers of the oropharynx (Rooper et al, 2016, Martens 2017). HPV status at baseline optional for oral cavity tumors.
7. Age 18 years or older
8. Patient must consent to the access, review, and analysis of previous medical and cancer history, including imaging data, by the sponsor or a third party nominated by the sponsor.
9. Ability and willingness to understand and sign a written informed consent document.
10. Women of childbearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been postmenopausal for at least 12 consecutive months
11. Adequate visual access to permit examination of the following oral cavity sites: lips, buccal mucosa, floor of mouth, ventral and lateral tongue, and soft palate.
Exclusion Criteria
2. Prior induction chemotherapy.
3. Tumors of the lips, salivary gland, nasopharynx, hypopharynx, or larynx.
4. Patients with simultaneous primaries
5. Stage IV, M1 (distant metastasis)
6. Prior or current use of approved or investigational anticancer agent other than those provided in this study.
7. Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity Criteria, version 5.0) or inability to eat a normal (solid) diet
8. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason or prophylactic insertion of gastrostomy tube with dependency on tube feeding at baseline.
9. Malignant tumors other than squamous cell carcinoma of the head and neck within last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator.
10. Active infectious disease excluding oral candidiasis.
11. Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at baseline.
12. Untreated active oral or dental infection
13. Known history of human immunodeficiency virus or active hepatitis B or C.
14. Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (e.g, immunosuppression, uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema)
15. Use of the following within 48 hours of enrollment and duration of Oral Mucositis follow up: vitamin B12 (cobalamin) or synthetic vitamin B12, cyanocobalamin, or the vitamin B12 precursor, cobinamide, or any supplement or multivitamin with vitamin B12 or vitamin E in it since both vitamin B12 and vitamin E interact negatively with RRx-001.
16. Use of prebiotics and probiotics
17. Pregnant or nursing.
18. Known allergies or intolerance to cisplatin or other platinum-containing compounds.
19. Sjogren syndrome
18 Years
ALL
No
Sponsors
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EpicentRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Meaghan Stirn
Role: STUDY_DIRECTOR
EpicentRx, Inc.
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
Miami Cancer Institute
Miami, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Parkview Cancer Institute
Fort Wayne, Indiana, United States
Willis Knighton Cancer Center
Shreveport, Louisiana, United States
Sandra and Malcolm Berman Cancer Institute
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Renown Regional Medical Center
Reno, Nevada, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
The Ohio State University James Cancer Hospital & Solove Research Institute
Columbus, Ohio, United States
Ballad Health
Johnson City, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
References
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Bonomi M, Blakaj DM, Kabarriti R, Colvett K, Takiar V, Biagioli M, Bar-Ad V, Goyal S, Muzyka B, Niermann K, Abrouk N, Oronsky B, Reid T, Caroen S, Sonis S, Sher DJ. PREVLAR: Phase 2a Randomized Trial to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Head and Neck Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):551-559. doi: 10.1016/j.ijrobp.2022.12.031. Epub 2023 Jan 14.
Other Identifiers
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K-01
Identifier Type: -
Identifier Source: org_study_id
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