Back to resultsVTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas
Primary Purpose
Low Grade B Cell Lymphoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VTX-2337 plus radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Grade B Cell Lymphoma focused on measuring B cell, lymphoma
Eligibility Criteria
Major Inclusion Criteria:
- low grade B cell lymphoma
- 1 or more sites of disease appropriate for intratumoral injection
- measurable disease other than the injection site
- Performance Status of 1 or better
- Adequate bone marrow, renal and hepatic function
- No active autoimmune disease or systemic immunosuppressive drugs
- Life expectancy > 4 months
Exclusion Criteria:
- Known HIV
- Known brain metastases
- Malignancy within last 5 yrs (basal cell or non-invasive squamous cell carcinoma OK)
- Anticoagulation therapy other than 325mg QD ASA
- Significant cardiovascular disease
- Pregnant or nursing
Sites / Locations
- Stanford Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
VTX-2337 plus radiation
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.
Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.
Secondary Outcome Measures
Assess the Safety and Feasibility of the Combination Regimen.
Full Information
NCT ID
NCT01289210
First Posted
February 1, 2011
Last Updated
September 23, 2019
Sponsor
Celgene
Collaborators
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT01289210
Brief Title
VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas
Official Title
A Phase I/II Study of Intratumoral Injection of the Small Molecule TLR8 Agonist VTX-2337 in Combination With Local Radiation in Low-Grade B-cell Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to slow rate of recruitment.
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
Collaborators
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug that stimulates the immune system) in combination with radiation therapy in treating patients with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9 intratumoral injections of VTX-2337 over the course of 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade B Cell Lymphoma
Keywords
B cell, lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VTX-2337 plus radiation
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
VTX-2337 plus radiotherapy
Intervention Description
Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
Primary Outcome Measure Information:
Title
Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.
Description
Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.
Time Frame
Tumor assessment conducted at 12 weeks and every 3-6 months thereafter
Secondary Outcome Measure Information:
Title
Assess the Safety and Feasibility of the Combination Regimen.
Time Frame
Safety assessed throughout study period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria:
low grade B cell lymphoma
1 or more sites of disease appropriate for intratumoral injection
measurable disease other than the injection site
Performance Status of 1 or better
Adequate bone marrow, renal and hepatic function
No active autoimmune disease or systemic immunosuppressive drugs
Life expectancy > 4 months
Exclusion Criteria:
Known HIV
Known brain metastases
Malignancy within last 5 yrs (basal cell or non-invasive squamous cell carcinoma OK)
Anticoagulation therapy other than 325mg QD ASA
Significant cardiovascular disease
Pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amar Patel, MD
Organizational Affiliation
Celgene
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas
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