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

Trial ID or NCT#

NCT01289210

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Ash A. Alizadeh, MD/PhD
Ash A. Alizadeh, MD/PhD
Medical oncologist, Lymphoma specialist, Cancer geneticist
Moghadam Family Professor
Manali Patel
Manali Patel
Medical oncologist
Associate Professor of Medicine (Oncology)

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Contact

Lori Richards
6507258589