Clinical trial NCT03235869: Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
Official title: A Single Arm Pilot Study of Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Cutaneous T Cell Lymphoma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The percentage of patients that respond to treatment
timeFrame: 1 year post treatment
measure: The percentage of patients that completely respond to treatment
timeFrame: 1 year post treatment
Secondary outcomes:
measure: Time to response
timeFrame: 1 year post treatment
measure: Duration of overall response
timeFrame: 1 year post treatment
measure: Progression free survival time
timeFrame: 1 year post treatment
measure: Time to next treatment
timeFrame: 1 year post treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: "Ryan Wilcox, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: