Clinical Trial: Phase I/II Study of Intratumoral Injection of CPG 7909, a TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides.
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Phase I/II Study of Intratumoral Injection of CPG 7909, A TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides
Brief Summary: This is a single institution phase I / II trial to evaluate the safety and efficacy of intratumoral CpG injections combined with local radiation in patients with mycosis fungoides. 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 24 hours before or 24 hours after each radiation treatment. Weekly doses of (intratumoral or peritumoral injections) CpG will be then administered subcutaneously in the region of previous injections for 23 additional doses. The total treatment duration is 24 weeks.
Detailed Summary:
Sponsor: Stanford University
Current Primary Outcome: Safety and efficacy of intratumoral CpG injections combined with local radiation
Original Primary Outcome:
Current Secondary Outcome:
- To determine local and systemic anti-tumor effect.
- To evaluate tumor-specific humoral and cellular immune responses
Original Secondary Outcome:
Information By: Stanford University
Dates:
Date Received: September 13, 2005
Date Started: March 2005
Date Completion:
Last Updated: November 29, 2016
Last Verified: November 2016
