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Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

Primary Purpose

Localized Skin Lesion, Mycosis Fungoides

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Quality-of-Life Assessment

Questionnaire Administration

Radiation Therapy

About this trial

This is an interventional treatment trial for Localized Skin Lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (ultra low dose radiation therapy)

Arm Description

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

Outcomes

Primary Outcome Measures

Local cutaneous control

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

Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion)

Will be described with frequency tables.

Overall survival

Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.

Progression free survival

Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.

Frequency/severity of skin toxicity

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.

Microbiome analysis

Will be described with frequency tables.

Quality of life

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.

Full Information

NCT ID

NCT03398161

First Posted

January 8, 2018

Last Updated

June 1, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03398161

Brief Title

Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

Official Title

Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 6, 2018 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Localized Skin Lesion, Mycosis Fungoides

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (ultra low dose radiation therapy)

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Other Intervention Name(s)

Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Intervention Description

Undergo ultra low dose radiation therapy

Primary Outcome Measure Information:

Title

Local cutaneous control

Description

Time Frame

At 12 (+/-2) weeks after initial treatment

Secondary Outcome Measure Information:

Title

Stable disease, progressive disease, or local regional control (local control within the radiation field margin but not encompassing the original treated lesion)

Description

Will be described with frequency tables.

Time Frame

Up to 2 years

Title

Overall survival

Description

Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.

Time Frame

From initiation of treatment until death, assessed up to 2 years

Title

Progression free survival

Description

Will be described with frequency tables. Will be conducted using the Kaplan Meier Method.

Time Frame

From treatment until progression or death, assessed up to 2 years

Title

Frequency/severity of skin toxicity

Description

Time Frame

Up to 14 weeks

Title

Microbiome analysis

Description

Will be described with frequency tables.

Time Frame

Up to 2 years

Title

Quality of life

Description

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bouthaina Dabaja, MD

Phone

713-563-2300

bdabaja@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bouthaina S Dabaja

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bouthaina S. Dabaja

Phone

713-563-2300

First Name & Middle Initial & Last Name & Degree

Bouthaina S. Dabaja

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Ultra Low Dose Radiation Therapy in Treating Patients With Mycosis Fungoides

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