We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03398161
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 15, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The goal of this clinical research study is to learn if low dose radiation therapy can help to control cutaneous mycosis fungoides.

Researchers would like to learn the level of effectiveness of this lower dose of radiation therapy because it is likely to have fewer side effects than the standard, higher dose.

This is an investigational study. It is investigational to treat cutaneous mycosis fungoides with lower doses of radiation than the standard, higher dose.

The study doctor can describe how the radiation therapy is designed to work.

Up to 50 participants will be enrolled in this study. All will be enrolled at MD Anderson.


Condition or disease Intervention/treatment Phase
Mycosis Fungoides Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic Radiation: Radiation Therapy Behavioral: Symptom Questionnaire Other: Photographs Procedure: Microbiome Analysis Phase 2

Detailed Description:

Radiation Treatment:

Radiation will be applied directly to the lesion on the skin. A lower energy form of radiation will be used that mostly affects only the first inch of skin. The doctor will use a marker to mark the area of the skin that needs to be treated. The radiation team will then perform a calculation that determines how long participant's treatment will last to deliver the right dose of radiation. The radiation will then be delivered by a certified radiation therapist using a radiation treatment machine.

Study Visits:

About 4-6 weeks after completion of radiation, participant will have a skin check, and a photograph will be taken of the affected area. If participant is unable to make this appointment, participant may submit an electronic photograph taken during this time interval or bring a photograph with participant to participant's next follow up visit. Participant will also complete the symptom questionnaire.

About 10-14 weeks after completion of radiation, an affected area and an unaffected area will be gently brushed with a cotton-like swab to test for bacteria. Participant will also complete the symptom questionnaire.

After this, participant will be scheduled to follow up again around 6-8 months after participant finishes treatment, then every 6-12 months until it has been about 2 years since participant completed radiation. At these visits:

  • Participant will have photographs taken of the affected area(s).
  • Participant will complete the questionnaire about your symptoms.

Additional visits may be scheduled if the doctor thinks it is needed.

Length of Study Participation:

Participant will be on study for about 2 years, or as long as the study doctor thinks it is in participant's best interest. Participant will no longer be able to take part if intolerable side effects occur or if participant is unable to follow study directions.

If participant leaves the study and the study doctor thinks it is needed, participant will receive the standard dose of radiation. In that case participant will sign a separate consent that explains the procedure, as well as its risks.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides
Actual Study Start Date : January 6, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Low Dose Radiation Therapy

Radiation applied directly to the lesion on the skin. Radiation delivered in 1 or 2 fractions.

Symptom questionnaire completed at baseline, 4-6 weeks after radiation, 1-14 weeks after radiation, 6-8 months after radiation, then every 6-12 months after radiation for 2 years.

Photographs taken of the affected area(s) at baseline, at 4-6 weeks after radiation, 6-8 months after radiation, then every 6-12 months after radiation for 2 years.

The lesion and unaffected skin swabbed for microbiome analysis at baseline, and at 10-14 weeks after radiation,

Radiation: Radiation Therapy
Radiation delivered in 1 or 2 fractions (including BID treatments to complete treatment in 1 day for patients receiving 4 Gy). Fractionation determined by the treating physician The total dose is 4 Gy.
Other Name: XRT
Behavioral: Symptom Questionnaire
Symptom questionnaire completed at baseline, 4-6 weeks after radiation, 1-14 weeks after radiation, 6-8 months after radiation, then every 6-12 months after radiation for 2 years.
Other Name: Survey
Other: Photographs
Photographs taken of the affected area(s) at baseline, at 4-6 weeks after radiation, 6-8 months after radiation, then every 6-12 months after radiation for 2 years.
Procedure: Microbiome Analysis
The lesion and unaffected skin swabbed for microbiome analysis at baseline, and at 10-14 weeks after radiation,


Outcome Measures

Primary Outcome Measures :
  1. Local Control in Management of Cutaneous Mycosis Fungoides (MF) with Low Dose Radiation [ Time Frame: 12 weeks after radiation therapy ]
    Local control defined as complete response (CR) or partial response (PR) of the treated lesion.


Secondary Outcome Measures :
  1. Overall Survival in Management of Cutaneous Mycosis Fungoides (MF) with Low Dose Radiation [ Time Frame: up to 2 years after radiation therapy ]
    Overall survival defined as the time from initiation of treatment until death; patients who are alive will be censored at the point of the last follow up visit.

  2. Progression Free Survival (PFS) in Management of Cutaneous Mycosis Fungoides (MF) with Low Dose Radiation [ Time Frame: up to 2 years after radiation therapy ]
    Progression free survival (PFS) defined as the time from treatment until progression or death; patients who are alive and without progression of disease will be censored at the last followup timepoint or at 2 years whichever is latest.

  3. Quality of Life in Management of Cutaneous Mycosis Fungoides (MF) with Low Dose Radiation [ Time Frame: Baseline, 4-6 weeks after radiation, 1-14 weeks after radiation, 6-8 months after radiation, then every 6-12 months after radiation for 2 years. ]
    Quality of life data obtained from the Skindex-16 survey summarized by domains.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 years or older at presentation with pathologically confirmed MF with cutaneous involvement. *Patients must have clinically measurable disease of at least 1 lesion on physical (skin) exam. *If a patient has a prior pathological diagnosis of MF and is clinically diagnosed with a new lesion, the new lesion is eligible for enrollment without additionally biopsy confirmation.
  2. Lesions of any surface span as long as </= 1 cm in maximal height measured from the skin surface for which local control is desired are eligible; a single patient may have multiple eligible lesions that are individually enrolled for the study.
  3. All stages of disease (IA through IVB) where radiation therapy is being considered for local control are eligible. Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.
  4. Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.
  5. Female patients of childbearing potential must have a negative serum pregnancy test (betahCG) within 2 weeks of protocol entry.
  6. Patients who are receiving or are planned to start topical chemotherapeutics, retinoids or imiquimod to other lesions that are not planned for enrollment are eligible; however, the lesion being considered for enrollment should not be under active therapy with these topical agents immediately prior to enrollment.

Exclusion Criteria:

  1. Pregnant or breast-feeding patients do not meet inclusion criteria for radiation therapy. *Patients who subsequently become pregnant may continue follow up within the protocol, but a negative urine pregnancy test will need to be obtained before additional lesions may be enrolled.
  2. Patients with active lupus or scleroderma
  3. Lesions with a height >1 cm measured from the skin surface are not eligible for this protocol.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398161


Contacts
Contact: Bouthaina Dabaja, MD 713-563-2300 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Bouthaina Dabaja, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03398161     History of Changes
Other Study ID Numbers: 2017-0276
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by M.D. Anderson Cancer Center:
Mycosis Fungoides
MF
Malignant neoplasms stated as primary lymphoid haematopoietic
Radiation therapy
XRT
Questionnaire
Survey
Photographs
Microbiome Analysis

Additional relevant MeSH terms:
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Mycoses
Mycosis Fungoides
Neoplasms
Dermatomycoses
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Skin Diseases, Infectious
Infection
Skin Diseases