Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer
This study is currently recruiting participants.
Verified September 2012 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: May 1, 2013
Last verified: September 2012
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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.
Secondary Outcome Measures:
- Evaluation of the following: rates and severity of skin toxicity, need for toxicity related treatment breaks, opiate requirements, disease status, HIV status, feasibility of collecting HIV RNA, cytology, and HPV studies.
| Estimated Enrollment: | 15 |
| Study Start Date: | March 2011 |
Intervention Details:
-
Drug: Tempol
N/A
Drug: 5-Fluorouracil
N/A
Drug: Mitomycin-C
N/A
Procedure: Radiation Therapy
N/A
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
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: | May 1, 2013 |
| 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 Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents |
ClinicalTrials.gov processed this record on June 18, 2013