Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
Primary Purpose
Cutaneous T Cell Lymphoma
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Durvalumab
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous T Cell Lymphoma
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.
Sites / Locations
- University of Michigan Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiation Therapy + Durvalumab
Arm Description
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.
Outcomes
Primary Outcome Measures
The percentage of patients that respond to treatment
Overall Response Rate (ORR) is defined as the percentage of patients that obtain a Complete Response (CR) or Partial Response (PR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
The percentage of patients that completely respond to treatment
Complete Response Rate (CRR) is defined as the percentage of patients that obtain Complete Response (CR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Secondary Outcome Measures
Time to response
The time to response is measured from the start of the treatment until criteria are met for CR or PR. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Duration of overall response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrence or PD (Progressive disease) is objectively documented. A global composite scoring system will be used to determine response and progression. Skin, nodes, viscera and blood will be assessed.
Progression free survival time
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. A global composite scoring system will be used to determine progression. Skin, nodes, viscera and blood will be assessed.
Time to next treatment
Time to next treatment is defined as the duration of time from start of study treatment to next treatment or death of any cause, whichever comes first.
Full Information
NCT ID
NCT03235869
First Posted
July 27, 2017
Last Updated
March 13, 2018
Sponsor
University of Michigan Rogel Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03235869
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The company pulled durvalumab from heme malignancies
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation Therapy + Durvalumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)
Primary Outcome Measure Information:
Title
The percentage of patients that respond to treatment
Description
Overall Response Rate (ORR) is defined as the percentage of patients that obtain a Complete Response (CR) or Partial Response (PR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Time Frame
1 year post treatment
Title
The percentage of patients that completely respond to treatment
Description
Complete Response Rate (CRR) is defined as the percentage of patients that obtain Complete Response (CR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Time Frame
1 year post treatment
Secondary Outcome Measure Information:
Title
Time to response
Description
The time to response is measured from the start of the treatment until criteria are met for CR or PR. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Time Frame
1 year post treatment
Title
Duration of overall response
Description
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrence or PD (Progressive disease) is objectively documented. A global composite scoring system will be used to determine response and progression. Skin, nodes, viscera and blood will be assessed.
Time Frame
1 year post treatment
Title
Progression free survival time
Description
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. A global composite scoring system will be used to determine progression. Skin, nodes, viscera and blood will be assessed.
Time Frame
1 year post treatment
Title
Time to next treatment
Description
Time to next treatment is defined as the duration of time from start of study treatment to next treatment or death of any cause, whichever comes first.
Time Frame
1 year post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
"Ryan Wilcox, M.D., Ph.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
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