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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01289210
Recruitment Status : Terminated (The study was stopped due to slow rate of recruitment.)
First Posted : February 3, 2011
Results First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Stanford University
Information provided by (Responsible Party):
VentiRx Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Low Grade B Cell Lymphoma Drug: VTX-2337 plus radiotherapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
VTX-2337 plus radiation Drug: 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.

Primary Outcome Measures :
  1. Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation. [ Time Frame: Tumor assessment conducted at 12 weeks and every 3-6 months thereafter ]
    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 :
  1. Assess the Safety and Feasibility of the Combination Regimen. [ Time Frame: Safety assessed throughout study period. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01289210

United States, California
Stanford Cancer Center
Stanford, California, United States, 94305
Sponsors and Collaborators
VentiRx Pharmaceuticals Inc.
Stanford University
Principal Investigator: Ronald Levy, MD Stanford University

Responsible Party: VentiRx Pharmaceuticals Inc. Identifier: NCT01289210     History of Changes
Obsolete Identifiers: NCT01396018
Other Study ID Numbers: VRXP-A104
First Posted: February 3, 2011    Key Record Dates
Results First Posted: October 6, 2014
Last Update Posted: October 6, 2014
Last Verified: September 2014

Keywords provided by VentiRx Pharmaceuticals Inc.:
B cell

Additional relevant MeSH terms:
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin