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Sponsors and Collaborators: |
Stanford University Lymphoma Research Foundation American Society of Clinical Oncology National Institutes of Health (NIH) |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00185965 |
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 |
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Lymphoma, Non-Hodgkin |
Drug: CPG 7909 Procedure: Local radiation |
Phase I Phase II |
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 |
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:
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Daniel Navi, MD 650-736-2300 dnavi@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 |
Principal Investigator: | Ronald Levy | Stanford University |
Study ID Numbers: | LYMNHL0014, 80057, LYMNHL0014, NCT00185965, NIH |
Study First Received: | September 12, 2005 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00185965 |
Health Authority: | United States: Institutional Review Board |
Lymphatic Diseases Immunoproliferative Disorders Lymphoproliferative Disorders |
Lymphoma, Non-Hodgkin Lymphoma Recurrence |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |