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A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

Primary Purpose

Cutaneous T-cell Lymphoma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Bexarotene

Total Skin Electron Beam (TSEB)

About this trial

This is an interventional treatment trial for Cutaneous T-cell Lymphoma focused on measuring Bexarotene, Radiotherapy, Mycosis Fungoides, 21-501

Eligibility Criteria

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

Inclusion Criteria:

Age ≥18 years
Pathologically confirmed cutaneous T-cell lymphoma consistent with mycosis fungoides (MF) based on biopsy done or reviewed at MSKCC
Stage IB or higher MF per ISCL/EORTC criteria; concurrent diagnosis of Sézary syndrome permissible. Patients who have not had prior systemic therapies and refractory/relapsed patients are eligible.
Baseline mSWAT score of at least 10
Stable topical steroids or systemic antipruritic agent (e.g. antihistamines, doxepin, GABA analogs) preceding study entry is permissible, but no new prescribed or over the counter topical or systemic anti-pruritics started post-enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Ability to provide informed consent

Exclusion Criteria:

Any oral retinoid therapy for any indication within 3 weeks of the first dose of study drug
Prior TSEB (prior focal skin-directed RT acceptable)
Concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL) or another non-Hodgkin lymphoma
Concurrent diagnosis of additional non-skin malignancy
Pregnancy
Patients unwilling to use two forms of barrier contraception while taking study medication
Receipt of treatment with another investigational device or drug (at present or within 2 weeks of enrollment)
Familial hypertriglyceridemia or other medical conditions in which use of bexarotene would be contraindicated
High likelihood of protocol non-compliance (in opinion of investigator)
Systemic steroids within two weeks of first dose of study drug (patients on systemic steroids for non-disease related conditions will be permitted per investigator discretion)

Prohibited concurrent medications

Gemfibrozil is contraindicated as may increase bexarotene concentrations
Bexarotene is a minor CYP3A4 substrate: avoid strong/moderate CYP3A4 inducers and inhibitors, if possible, but concomitant use is not a contraindication Bexarotene is a moderate CYP3A4 inducer: avoid concurrent administration with CYP3A4 sensitive substrates, for which minimal concentration changes may lead to therapeutic failures of the substrate (e.g. cyclosporine, tacrolimus, sirolimus, quinidine, fentanyl), if possible

Sites / Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bexarotene Combined With Radiotherapy

Arm Description

Patients will be initiated on bexarotene 150 mg daily on Day 1, with dose increase to 300 mg daily on Day 15. Patients will receive Cycle 1 of TSEB on Day 22 (with 2 Gy given on two consecutive days -Day 22 and 23), with safety assessment on Day 52. Efficacy will first be assessed on Day 52 and then again on Day 82 by global response assessment, including mSWAT. Patients who have less than 70% reduction from baseline mSWAT score will be eligible for subsequent cycles of TSEB (administered as 4 Gy over 2 consecutive days), until mSWAT score reduction of ≥ 70%, and up to a total of 6 cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by treating physician, or termination of the study.

Outcomes

Primary Outcome Measures

Incidence of radiation dermatitis grade 3+

as defined by number of patients who develop CTCAE, v. 5, grade 3+ toxicities at 1 month post-treatment.

Secondary Outcome Measures

Overall skin response rate

For patients with mycosis fungoides without blood involvement, the response criteria will be based upon modified international consensus guidelines.26 Specifically, skin response will be assessed by the Modified Severity Weighted Assessment Tool (mSWAT). For the purposes of this protocol, overall skin response will be considered to be either CR or PR.

Full Information

NCT ID

NCT05296304

First Posted

March 16, 2022

Last Updated

June 5, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05296304

Brief Title

A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

Official Title

A Phase Ib Trial Combining Bexarotene With Ultra-Low Dose Total Skin Electron Beam (Tseb) Radiotherapy For The Treatment Of Diffuse Cutaneous T-Cell Lymphomas

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 16, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The researchers are doing this study to test the safety of combining bexarotene with TSEB radiotherapy in people who have a common form of CTCL called mycosis fungoides (MF). Bexarotene is a form of vitamin A that activates proteins called retinoid X receptors, which may stop the growth of cancer cells and kill them. TSEB radiotherapy is a type of radiation therapy that treats the entire surface of the skin with very low doses of radiation to kill cancer cells and shrink tumors. This type of radiation does not pass through the outer layers of the skin into the tissues and organs below the skin. The study researchers think that giving bexarotene treatment at the same time as treatment with TSEB radiotherapy may be more effective against MF than either treatment given alone or in sequence (one after the other).

6. Conditions and Keywords

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

Cutaneous T-cell Lymphoma

Keywords

Bexarotene, Radiotherapy, Mycosis Fungoides, 21-501

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

This is a Phase I, single-arm therapeutic study for patients with diffuse cutaneous T-cell lymphomas (CTCL).

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bexarotene Combined With Radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bexarotene

Other Intervention Name(s)

Targretin®

Intervention Description

Orally every day starting at the dose of 150 mg/day flat dose. At Day 15, if the treatment is tolerated, patients will escalate the dose of bexarotene to 300 mg/day, and that dose will remain constant during the rest of the study.

Intervention Type

Radiation

Intervention Name(s)

Total Skin Electron Beam (TSEB)

Intervention Description

At Day 21, if the bexarotene has shown to be tolerated, patients will receive the first dose of TSEB (2 Gy x 2).

Primary Outcome Measure Information:

Title

Incidence of radiation dermatitis grade 3+

Description

as defined by number of patients who develop CTCAE, v. 5, grade 3+ toxicities at 1 month post-treatment.

Time Frame

1 month post-treatment

Secondary Outcome Measure Information:

Title

Overall skin response rate

Description

Time Frame

up to 82 days post-TSEB

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years Pathologically confirmed cutaneous T-cell lymphoma consistent with mycosis fungoides (MF) based on biopsy done or reviewed at MSKCC Stage IB or higher MF per ISCL/EORTC criteria; concurrent diagnosis of Sézary syndrome permissible. Patients who have not had prior systemic therapies and refractory/relapsed patients are eligible. Baseline mSWAT score of at least 10 Stable topical steroids or systemic antipruritic agent (e.g. antihistamines, doxepin, GABA analogs) preceding study entry is permissible, but no new prescribed or over the counter topical or systemic anti-pruritics started post-enrollment Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Ability to provide informed consent Exclusion Criteria: Any oral retinoid therapy for any indication within 3 weeks of the first dose of study drug Prior TSEB (prior focal skin-directed RT acceptable) Concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL) or another non-Hodgkin lymphoma Concurrent diagnosis of additional non-skin malignancy Pregnancy Patients unwilling to use two forms of barrier contraception while taking study medication Receipt of treatment with another investigational device or drug (at present or within 2 weeks of enrollment) Familial hypertriglyceridemia or other medical conditions in which use of bexarotene would be contraindicated High likelihood of protocol non-compliance (in opinion of investigator) Systemic steroids within two weeks of first dose of study drug (patients on systemic steroids for non-disease related conditions will be permitted per investigator discretion) Prohibited concurrent medications Gemfibrozil is contraindicated as may increase bexarotene concentrations Bexarotene is a minor CYP3A4 substrate: avoid strong/moderate CYP3A4 inducers and inhibitors, if possible, but concomitant use is not a contraindication Bexarotene is a moderate CYP3A4 inducer: avoid concurrent administration with CYP3A4 sensitive substrates, for which minimal concentration changes may lead to therapeutic failures of the substrate (e.g. cyclosporine, tacrolimus, sirolimus, quinidine, fentanyl), if possible

Central Contact Person:

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

Brandon Imber, MD, MS

Phone

631-212-6346

imberb@mskcc.org

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

Shamir Geller

gellers@mskcc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brandon Imber, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brandon Imber, MD

Phone

631-212-6346

First Name & Middle Initial & Last Name & Degree

Shamir Geller

gellers@mskcc.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

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A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

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