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

Learn more about:
Related Clinical Trial
CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers Assessment of Patients’ Quality of Sexual Life After Anal Cancer Treatment Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5) Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors Detecting HPV DNA in Anal and Cervical Cancers ANCA II – Quality of Life and Functional Outcome in Patients With Anal Cancer RTX-321 Monotherapy in Patients With HPV 16+ Tumors Anal Injury Screening for High Risk HPV M7824 in Subjects With HPV Associated Malignancies Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies Function Following Laser for Anal Intraepithelial Neoplasia (FLAN) A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer Phase 2 Study of ADXS11-001 in Subjects With Carcinoma of the Anorectal Canal Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula HPV-SAVE: 9-Valent HPV Vaccine for High-Grade Anal Dysplasia Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men High-Resolution Anoscopy Perceived Discomfort Study Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia Image Fusion PET, CT and 3D-ultrasound Examinations Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV Molecular Genetic and Pathological Studies of Anal Tumors Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy Screening for HIV-Associated Anal Cancer Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE) Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer Prospective Cohort on Quality of Sexual Life Among Men Who Have Sex With Men Treated for Anal Cancer With Concurrent Chemotherapy and Intensity-modulated Radiotherapy Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Anal Cancer Radiotherapy Study Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer Individual Following in Anal Cancer With PET/CT Anal Cancer Screening Study The Prevent Anal Cancer Self-Swab Study Shared Decision Making With Anal Cancer Patients on Radiation Dose Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy Quality of Life in Patients With Anal Cancer Functional Outcomes Following Anal Cancer Treatment Pembrolizumab in Refractory Metastatic Anal Cancer A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer

Brief Title

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

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

Brief Summary


      - 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


      - 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.

Detailed Description


        -  Patients with non-metastatic carcinoma of the anal canal are treated with concurrent
           mitomycin C (MMC), 5-fluorouracil (5-FU), and radiotherapy (RT) in the curative setting
           in an attempt to preserve the anal sphincter.

        -  Radiation dermatitis is a uniform complication of this therapy which frequently results
           in treatment delay due to pain and discomfort. High grade dermatitis may also become
           superinfected in the setting of decreased blood counts from chemotherapy and diarrhea
           from radiation proctitis, further delaying therapy. Approaches that decrease toxicity
           may be particularly important in patients infected with human immunodeficiency virus

        -  MTS-01 (tempol, 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) is a piperidine
           nitroxide known to act as a chemical radioprotector with selective protection of normal
           versus tumor tissue.

        -  Tempol gel (tempol 70 mg/mL plus water, ethanol, and hydroxypropyl cellulose) has been
           evaluated as a topical radioprotector in pilot trials that included a variety of sites.


        -  Primary Objective: 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 Objectives will include evaluation of the following endpoints in a preliminary

             -  To describe the rates and severity of skin toxicity in patients treated with this

             -  To describe the need for toxicity related treatment breaks with this regimen

             -  To describe the opiate requirements in patients treated with this regimen

             -  To describe 12-month progression-free survival, disease-free survival, and overall
                survival in patients treated with concurrent chemotherapy, radiation therapy, and

             -  Evaluate the effects of antiretroviral therapy, 5-fluorouracil, mitomycin C, and
                radiation on low level persistent HIV viremia and HIV genetic diversity during
                therapy and recovery

             -  To evaluate the feasibility of collecting HIV ribonucleic acid (RNA) and
                mononuclear cells from rectal associated lymphoid tissue for correlative studies

             -  Collect and store anal cytology and core needle biopsies of tumor for future human
                papillomavirus infection (HPV) and tumor based analyses


        -  Age greater than or equal to 18 years.

        -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.

        -  Histologically confirmed carcinoma of the anal canal without evidence of distant

        -  No contraindications to definitive chemoradiotherapy for carcinoma of the anal canal


      This is a pilot trial of topical MTS-01 in patients receiving MMC, 5-FU, and
      intensity-modulated radiation therapy (IMRT) for definitive management of carcinoma of the
      anal canal. Fifteen patients will be enrolled. MMC will be delivered at a dose of 10mg/m(2)
      on days 1 and 29. 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion
      beginning on day 1 and 29. RT will be delivered to a total dose of 50-54 Gy based on tumor
      characteristics. 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.
      Radiation Therapy Oncology Group (RTOG) grading will be used to evaluate skin toxicity in
      both the groin and gluteal cleft weekly during treatment and at 4 weeks, 3 months and 6
      months after completion of treatment. The duration of treatment, number of treatment breaks,
      opiate requirements, and level of pain will be evaluated weekly during treatment and at 4
      weeks and 3 months after the completion of treatment. Disease control will be assessed at 4
      weeks, 3 months, 6 months, 9 months, and 12 months of follow-up.

Study Phase

Phase 1

Study Type


Primary Outcome

Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT)

Secondary Outcome

 Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment


Anal Cancer



Study Arms / Comparison Groups

 1/Chemo + Radiation
Description:  Chemo + Radiation


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

March 18, 2011

Completion Date

April 15, 2015

Primary Completion Date

April 15, 2015

Eligibility 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

          -  Eastern Cooperative Oncology Group (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 Cockcroft-Gault formula

               -  Bilirubin less than or equal to 1.5 times upper limit of normal (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.

               -  White blood cell (WBC) greater than or equal to 3,000/microL

               -  Alanine aminotransferase (ALT)/aspartate aminotransferase (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


          -  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

          -  Human immunodeficiency virus (HIV) positive patients with cluster of differentiation 4
             (CD4) < 100 cells/mL AND ECOG performance status (PS) greater than 2.

          -  Dermatitis in the anticipated radiation treatment portal.




18 Years - 90 Years

Accepts Healthy Volunteers



Deborah E Citrin, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party

Principal Investigator

Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Deborah E Citrin, M.D., Principal Investigator, National Cancer Institute (NCI)

Verification Date

October 2021