Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer

• Status: Terminated
• Trial end date: 2015-04-15
• Target enrollment: 0
• Participant gender: All

Summary

Background:

• 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.

Objectives:

• 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.

Eligibility:

• 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.

Design:

• 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fluorouracil; Mitomycin; Mitomycins; Tempol

Criteria

• INCLUSION CRITERIA:

• Histologically proven, invasive primary squamous, basaloid, or cloacogenic carcinoma of the anal canal, stage T1-4, N0-3

• No previous therapy for anal cancer.

• Age greater than or equal to 18 years

• ECOG performance status less than or equal to 2

• Adequate bone marrow, renal, and hepatic function defined as

• Absolute neutrophil count greater than or equal to 1,000 cells/mm(3)

• Platelet count greater than or equal to 100,000/mm(3)

• Hemoglobin greater than or equal to 8mg/dL

• Creatinine clearance > 60 mL/min using Cockroft-Gault formula

• Bilirubin less than or equal to 1.5 times ULN unless, during screening, the patient is receiving protease inhibitor therapy (i.e. indinavir, ritonavir, nelfinavir, and atazanavir) known to be associated with increased bilirubin: in this case total bilirubin less than or equal to 7.5 mg/dl and the direct fraction is less than or equal to 0.7 mg/dl.

• WBC greater than or equal to 3,000/microL

• ALT/AST less than or equal to 3 times the upper limit of normal

• International normalized ratio (INR) less than or equal to 1.5

• Patients of childbearing potential must be willing to use a medically effective means of birth control for the duration of treatment and six weeks after treatment.

• Patients must be willing and able to provide informed consent

EXCLUSION CRITERIA:

• Contraindications to radiotherapy such as a history of prior radiotherapy to the pelvis or a history of inflammatory bowel disease

• Prior malignancy except:

• non-melanoma skin cancer

• controlled Kaposi s Sarcoma (no chemotherapy for KS for 3 months, and no expected need for chemotherapy for the 12-month period of the study)

• other malignancies with disease free period of at least 3 years

• Presence of metastatic disease (M1)

• Co-morbidity that in the estimation of the principal investigator would make the patient unable to tolerate treatment

• Pregnant or lactating females

• HIV positive patients with CD4 < 100 cells/mL AND ECOG PS greater than 2.

• Dermatitis in the anticipated radiation treatment portal.