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

NCT ID: NCT01289210

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-10-31

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.

Conditions

Low Grade B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VTX-2337 plus radiation

Group Type: OTHER

VTX-2337 plus radiotherapy

Intervention Type: DRUG

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.

Interventions

VTX-2337 plus radiotherapy

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amar Patel, MD

Role: STUDY_DIRECTOR

Celgene

Locations

Stanford Cancer Center

Stanford, California, United States

Countries

United States

Other Identifiers

VRXP-A104

Identifier Type: -

Identifier Source: org_study_id

NCT01396018

Identifier Type: -

Identifier Source: nct_alias