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

This is a single institution phase I / II 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.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : CPG 7909

Phase: Phase 1/Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

Patients must meet all of the following criteria in order to be eligible for entry into the trial. - Biopsy confirmed low-grade B-cell lymphoma of any initial stage or mycosis fungoides of stage IB-IVA. B-cell lymphoma patients must have failed at least one prior treatment. Mycosis fungoides patients must have failed or have been intolerant of at least 2 topical or one systemic treatment. - Patients must have at least one site of disease that is accessible for intratumoral injection of CpG percutaneously - Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the treatment. - Patients must have measurable disease other than the injection site or biopsy site. - 18 years of age or older - Karnofsky Performance Status (KPS) of > 70. - Adequate bone marrow function: WBC>4,000uL, hemoglobin > 10g/dL; platelet count >100,000/mm3; ANC> 1000. - Adequate hepatic function: bilirubin <= 1.5 mg/dL; SGOT/SGPT<3xupper limit of normal - Adequate renal function: serum creatinine <= 2.0mg/dL. - Required wash out periods for prior therapy: - Topical therapy: 2 weeks - Chemotherapy: 4 weeks - Radiotherapy (including photo therapy): 4 weeks - Systemic biological therapy for mycosis fungoides: 4 weeks - Other investigational therapy: 4weeks - Rituximab: 12 weeks - Patients of reproductive potential and their partners must agree to use an effective (>90% reliability) form of contraception during the study and for 4 weeks following the last study drug administration. - Women of reproductive potential must have negative urine pregnancy test. - Life expectancy greater than 4 months. - Able to comply with the treatment schedule.

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