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

This study has been terminated.
(The study was stopped due to slow rate of recruitment.)
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
VentiRx Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01289210
First received: February 1, 2011
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by VentiRx Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Determine the anti-tumor effects of intratumoral injection of VTX-2337 in combination with low-dose local radiation. [ Time Frame: Tumor assessment conducted every 8-12 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and feasibility of the combination regimen. [ Time Frame: Safety assessed throughout study period. ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
VTX-2337 plus radiation Drug: VTX-2337 plus radiotherapy
A small-molecule Toll-like receptor 8 agonist (VTX-2337) in combination with low-dose radiation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289210

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

No publications provided

Responsible Party: VentiRx Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01289210     History of Changes
Obsolete Identifiers: NCT01396018
Other Study ID Numbers: VRXP-A104
Study First Received: February 1, 2011
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by VentiRx Pharmaceuticals Inc.:
B cell
lymphoma

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

ClinicalTrials.gov processed this record on May 22, 2013