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| Sponsor: | Stanford University |
|---|---|
| Collaborators: |
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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:
Exclusion Criteria:A patient may not be enrolled in the trial if any of the following criteria are met.
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Ronald Levy | Stanford University |
More Information
| Responsible Party: | Ronald Levy, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00185965 History of Changes |
| Other Study ID Numbers: | LYMNHL0014, 80057, LYMNHL0014, NIH |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 13, 2010 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |