Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2023-03-01

Brief Summary

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This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).

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Detailed Description

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Conditions

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Cutaneous T Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiation Therapy + Durvalumab

Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.

Radiation Therapy

Intervention Type RADIATION

Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)

Interventions

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Durvalumab

Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.

Intervention Type DRUG

Radiation Therapy

Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Voluntarily provide written IRB-approved consent
* Age ≥ 18 years
* Histologically proven CTCL
* Stage IIB-IV CTCL with ≥2 cutaneous tumors assessable for response
* At least one cutaneous tumor amenable to radiation therapy. Must have at least 1 tumor assessable for response that will not undergo radiation.
* Adequate organ function
* Prior treatment is allowed if at least 4 weeks have elapsed since last chemotherapy and/or radiation and the subject has recovered from all treatment related toxicity

Exclusion Criteria

* Prior allogeneic stem cell transplant.
* Prior treatment with a PD-1/PD-L1 inhibitor
* Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment.
* Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab.
* Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
* History of hypersensitivity to durvalumab or any excipient
* Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab.
* Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control
* Male subjects who are not employing an effective method of birth control
* Uncontrolled current medical illness, including, but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris,unstable cardiac arrhythmia and/or psychiatric illness or other condition that in the opinion of the investigator would limit compliance with study requirements.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No