Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer
- Radiation and chemotherapy treatments for anal cancer can cause irritation of the skin that can lead to redness and tenderness, and in some cases can be so severe that it results in blistering or peeling of the skin during treatment. These conditions cause discomfort and may require breaks from radiation treatment. Researchers are interested in determining whether MTS-01, a drug that protects cells and tissues from the effects of radiation, can be given before radiation treatment to prevent these side effects and reduce the irritation of the skin during chemotherapy and radiation for anal cancer.
- To determine the safety and effectiveness of topical MTS-01 given before radiation in the groin and gluteal cleft of patients receiving combined radiation and chemotherapy for anal cancer.
- Individuals at least 18 years of age who have been diagnosed with cancer of the anal canal and are eligible to receive radiation and chemotherapy treatments.
- Participants will be screened with a physical examination, medical history, blood tests, imaging studies and physical examination of the anal canal, and biopsies as needed to evaluate eligibility for treatment.
- Participants will be scheduled for radiation and chemotherapy treatments on the following schedule:
- Radiation given 5 days per week for 6 weeks, with topical MTS-01 treatment on the skin in the groin areas and between the buttocks before each treatment
- Mitomycin C given intravenously on days 1 and 29 of treatment
- 5-Fluorouracil given intravenously over 4 days (first week and fifth week) during radiation treatment
- Participants will be monitored throughout the treatment for side effects, with photographs of the treatment area and frequent blood tests.
- Following the end of radiation, participants will have followup visits for 1 year with blood tests and imaging studies to evaluate the response to treatment.
|Anal Cancer||Drug: Tempol Drug: 5-Fluorouracil Drug: Mitomycin-C Procedure: Radiation Therapy||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Trial Assessing the Feasibility of Delivering Topical MTS-01 to Reduce Dermatitis in Patients Receiving Intensity Modulated Radiation With Concurrent 5-Fluorouracil and Mitomycin-C for Stage I-III Carcinoma of the Anal Canal|
- To determine the safety and tolerability of topical MTS-01 on a daily basis prior to irradiation in the groin and gluteal cleft of patients receiving combined therapy with MMC, 5-FU, and RT for carcinoma of the anal canal. [ Time Frame: Completion of study ]
- To describe the rates and severity of skin toxicity in patients treated with this regimen [ Time Frame: Completion of study ]
- To describe the need for toxicity related treatment breaks with this regimen [ Time Frame: Completion of study ]
- To describe the opiate requirements in patients treated with this regimen [ Time Frame: Completion of study ]
- To describe 12-month progression-free survival, disease-free survival, and overall survival in patients treated with concurrent chemotherapy, radiation therapy, MTS-01 [ Time Frame: Completion of study ]
- Evaluate the effects of antiretroviral therapy, 5-fluorouracil, mitomycin C, and radiation on low level persistent HIV viremia and HIV genetic diversity [ Time Frame: Completion of study ]
- To evaluate the feasibility of collecting HIV RNA and mononuclear cells from rectal associated lymphoid tissue for correlative studies [ Time Frame: Completion of study ]
- Collect and store anal cytology and core needle biopsies of tumor for future HPV and tumor based analyses [ Time Frame: Completion of study ]
|Study Start Date:||March 18, 2011|
|Study Completion Date:||April 15, 2015|
|Primary Completion Date:||April 15, 2015 (Final data collection date for primary outcome measure)|
Chemo + Radiation
Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of RT.Drug: 5-Fluorouracil
5-FU will be delivered as 1000mg/m2/day as 96 hour continuous infusion beginning on day 1 and 29.Drug: Mitomycin-C
MMC will be delivered at a dose of 10mg/m2 on days 1 and 29Procedure: Radiation Therapy
RT will be delivered to a total dose of 50-54 Gy based on tumor characteristics.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01324141
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Deborah E Citrin, M.D.||National Cancer Institute (NCI)|