VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; VentiRx Pharmaceuticals Inc.
• Collaborator: Stanford University

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