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Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

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ClinicalTrials.gov Identifier: NCT03398161
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : December 14, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This phase II trial studies how well ultra low dose radiation therapy works in treating patients with mycosis fungoides. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ultra low doses of radiation may help control the disease and reduce side effects compared to treatment with higher doses.

Condition or disease Intervention/treatment Phase
Localized Skin Lesion Mycosis Fungoides Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of low dose radiation in the management of cutaneous mycosis fungoides (MF), measured as any local control for each lesion at 12 (+/- 2) weeks after the treatment, in patients with stage IA - IVB cutaneous MF.

SECONDARY OBJECTIVES:

I. To evaluate complete response (CR) rates at 12 (+2) weeks and beyond.

II. To evaluate the persistence of response (CR, partial response [PR], stable disease, or progressive disease) in the treated lesion beyond 12 (+2) weeks.

III. To evaluate overall survival.

IV. To evaluate progression free survival.

V. To evaluate patient symptom relief.

VI. To evaluate the toxicity of radiation to the skin.

VII. To assess if number of previous therapies including chemotherapy, targeted therapy, topical therapy, or total skin radiation affects the response.

VIII. To characterize the microbiome of mycosis fungoides patient within both the lesion and unaffected skin.

IX. To characterize shifts in the microbiome that occur after radiation therapy.

OUTLINE:

Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 4-6 and 10-14 weeks, every 3 months for 6-8 months, then every 6-12 months for up to 2 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
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 : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (ultra low dose radiation therapy)
Patients undergo ultra low dose radiation therapy at the discretion of the treating physician.
 Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Radiation Therapy
Undergo ultra low dose radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation


Outcome Measures
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Primary Outcome Measures :
  1. Local cutaneous control [ Time Frame: At 12 (+/-2) weeks after initial treatment ]
    Defined as local control of the treated lesion within the radiation treatment field, which will be categorized as either complete response or partial response of the lesion within the radiation treatment field. The control rate will be estimated along with 95% confidence intervals. The association between control rate and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. For each patient, the number of lesions under control will be summarized individually. Since there may be multiple lesions per patient, a generalized linear mixed model will be utilized to assess the clinical factor effect (e.g. previous therapies) on control rate after considering the dependence among the lesions within each patient.


Secondary Outcome Measures :
  1. Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion) [ Time Frame: Up to 2 years ]
    Will be described with frequency tables.

  2. Overall survival [ Time Frame: From initiation of treatment until death, assessed up to 2 years ]
    Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.

  3. Progression free survival [ Time Frame: From treatment until progression or death, assessed up to 2 years ]
    Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.

  4. Frequency/severity of skin toxicity [ Time Frame: Up to 14 weeks ]
    Defined by patient reported symptom surveys. Toxicity type (acute or chronic), severity and attribution will be summarized for each patient using frequency tables. Different time points (e.g. pre and post-treatment) will be compared using a paired t-test or Wilcoxon signed rank test as appropriate.

  5. Microbiome analysis [ Time Frame: Up to 2 years ]
    Will be described with frequency tables.

  6. Quality of life [ Time Frame: Up to 2 years ]
    Will be assessed by the Skindex-16 survey. Will be summarized by domains. Different time points (e.g. pre and post-treatment) will be compared using a paired t-test or Wilcoxon signed rank test as appropriate.


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

Inclusion Criteria:

  • Patients 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.
  • 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.
  • 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.
  • Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.
  • Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry if the patient is unsure of their pregnancy status. Patient signature declaring that they are not pregnant on the informed consent for treatment that is used in the Department of Radiation Oncology is also an acceptable substitution for a serum pregnancy test.

  • 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.

    • Use of topical chemotherapeutics, retinoids or imiquimod on the lesion that is a candidate for enrollment must be halted at least 24 hours prior to enrollment in the study.

Exclusion Criteria:

  • Pregnant 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.
  • Patients with active lupus or scleroderma
  • Lesions with a height > 1 cm measured from the skin surface are not eligible for this protocol.
Contacts and Locations
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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
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Contact: Bouthaina Dabaja, MD 713-563-2300 bdabaja@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Bouthaina S. Dabaja    713-563-2300      
Principal Investigator: Bouthaina S. Dabaja         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bouthaina S Dabaja M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03398161    
Other Study ID Numbers: 2017-0276
NCI-2018-00861 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0276 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycoses
Mycosis Fungoides
Bacterial Infections and Mycoses
Infections
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
 Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases