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: September 29, 2014
Last verified: September 2014
  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:


Further study details as provided by VentiRx Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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
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.

  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
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, see Learn About Clinical Studies.

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
Results First Received: May 28, 2014
Last Updated: September 29, 2014
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 22, 2014