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

Low Grade B Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01289210
• Other study ID #: VRXP-A104
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: September 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01396018

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Cancer Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Celgene	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.	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.	Tumor assessment conducted at 12 weeks and every 3-6 months thereafter
Secondary	Assess the Safety and Feasibility of the Combination Regimen.		Safety assessed throughout study period.