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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01324141
First received: March 25, 2011
Last updated: July 18, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention Phase
Anal Cancer
Drug: Tempol
Drug: 5-Fluorouracil
Drug: Mitomycin-C
Procedure: Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe the rates and severity of skin toxicity in patients treated with this regimen [ Time Frame: Completion of study ] [ Designated as safety issue: Yes ]
  • To describe the need for toxicity related treatment breaks with this regimen [ Time Frame: Completion of study ] [ Designated as safety issue: Yes ]
  • To describe the opiate requirements in patients treated with this regimen [ Time Frame: Completion of study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the feasibility of collecting HIV RNA and mononuclear cells from rectal associated lymphoid tissue for correlative studies [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Collect and store anal cytology and core needle biopsies of tumor for future HPV and tumor based analyses [ Time Frame: Completion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chemo + Radiation
Drug: Tempol
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 29
Procedure: Radiation Therapy
RT will be delivered to a total dose of 50-54 Gy based on tumor characteristics.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324141

Contacts
Contact: Deborah S Cooley, R.N. (301) 451-8904 cooleyd@mail.nih.gov
Contact: Deborah E Citrin, M.D. (301) 496-5457 citrind@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Deborah E Citrin, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01324141     History of Changes
Other Study ID Numbers: 110129, 11-C-0129
Study First Received: March 25, 2011
Last Updated: July 18, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Anal Cancer
Radioprotector
Topical
Radiation
Dermatitis

Additional relevant MeSH terms:
Anus Neoplasms
Dermatitis
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Skin Diseases
Mitomycins
Mitomycin
Fluorouracil
Tempol
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 31, 2014