NCT00185965

CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas

Le23 CPG: A Phase 1-2 Study of Intratumoral Injection of CPG 7909, A TLR 9 Agonist, Combined With Local Radiation in Recurrent Low-Grade Lymphomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ronald Levy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Brief summary TBD

Detailed description

This is a single institution phase 1-2 trial to evaluate the safety, feasibility and efficacy of CpG injections (4 intratumoral injections followed by 6 peri-tumoral injections) combined with local irradiation in patients with recurrent low-grade lymphomas. Patients will receive low-dose radiotherapy to a single tumor site on days 1 and 2 (2 Gy each day). CpG injections will be administered into the same tumor site within the 24 hours before and the 24 hours after the radiation, and on days 8 and 15. Weekly doses of CpG will be then administered subcutaneously in the region of previous injections for 6 additional doses.

Conditions

• Non-Hodgkin Lymphoma
• Mycosis Fungoides

Interventions

Type	Name	Description
DRUG	CPG 7909	6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Timeline

• Start date: 2004-07-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2005-09-16
• Last updated: 2014-08-01
• Results posted: 2014-08-01

Locations

1 site across 1 country: United States