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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Low Grade B Cell Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the anti-tumor effects of intratumoral injection of VTX-2337 in combination with low-dose local radiation.

Outcome Time Frame:

Tumor assessment conducted every 8-12 weeks.

Safety Issue:

No

Principal Investigator

Ronald Levy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

VRXP-A104

NCT ID:

NCT01289210

Start Date:

July 2011

Completion Date:

October 2012

Related Keywords:

  • Low Grade B Cell Lymphoma
  • B cell
  • lymphoma
  • Lymphoma
  • Lymphoma, B-Cell

Name

Location
Stanford Cancer Center Stanford, California  94305-5824