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| Sponsors and Collaborators: |
Stanford University Lymphoma Research Foundation American Society of Clinical Oncology National Institutes of Health (NIH) |
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00185965 |
Purpose
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.
| Condition | Intervention | Phase |
|
Lymphoma, Non-Hodgkin |
Drug: CPG 7909 Procedure: Local radiation |
Phase I Phase II |
| MedlinePlus related topics: | Lymphoma |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2004 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:Patients must meet all of the following criteria in order to be eligible for entry into the trial.
Required wash out periods for prior therapy:
Contacts and Locations| United States, California | |||||
| Stanford University School of Medicine | Recruiting | ||||
| Stanford, California, United States, 94305 | |||||
| Contact: Mayita Romero 650-725-6452 mayitar@stanford.edu | |||||
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |||||
| Principal Investigator: Ronald Levy | |||||
| Sub-Investigator: Weiyun Ai | |||||
| Sub-Investigator: Joshua Brody | |||||
| Sub-Investigator: Richard T. Hoppe | |||||
| Sub-Investigator: Sandra Jeane Horning | |||||
| Sub-Investigator: Youn H Kim | |||||
| Sub-Investigator: Susan J Knox | |||||
| Sub-Investigator: Sabine Kohler | |||||
| Sub-Investigator: Irene L. Wapnir | |||||
| Stanford University |
| Lymphoma Research Foundation |
| American Society of Clinical Oncology |
| National Institutes of Health (NIH) |
| Principal Investigator: | Ronald Levy | Stanford University |
More Information
| Study ID Numbers: | LYMNHL0014, LYMNHL0014, NCT00185965, NIH |
| First Received: | September 12, 2005 |
| Last Updated: | December 4, 2007 |
| ClinicalTrials.gov Identifier: | NCT00185965 |
| Health Authority: | United States: Food and Drug Administration |
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