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| Sponsor: | Stanford University |
|---|---|
| Collaborator: |
VentiRx Pharmaceuticals Inc. |
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01396018 |
Purpose
The primary objective is to determine the local and systemic anti-tumor effects of intratumoral injection of VTX-2337, a TLR8 agonist, in combination with low-dose local radiation at a single tumor site, in patients with recurrent b-cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Non-Hodgkin Cutaneous Lymphoma Large B Cell Diffuse Lymphoma Mantle Cell Lymphoma Marginal Zone B-Cell Lymphoma Peripheral T-cell Lymphoma, Large Cell Waldenstrom Macroglobulinemia |
Procedure: CT Scan Procedure: local radiotherapy Drug: VTX-2337 |
Phase 1 Phase 2 |
| 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: | A Phase I/II Study of Intratumoral Injection of the Small Molecule TLR8 Agonist VTX-2337 in Combination With Local Radiation in Low-Grade B-cell Lymphomas |
| Estimated Enrollment: | 15 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | May 2013 (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:
A patient must meet all of the following criteria in order to be enrolled:
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| Contact: Lori Richards | (650) 725-4968 | lorir@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Lori Richards 650-725-4968 lorir@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 ccto-office@stanford.edu | |
| Principal Investigator: Ronald Levy | |
| Sub-Investigator: Joshua Brody | |
| Principal Investigator: | Ronald Levy | Stanford University |
More Information
| Responsible Party: | Ronald Levy, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01396018 History of Changes |
| Other Study ID Numbers: | SU-04262011-7706, LYMNHL0086 |
| Study First Received: | July 6, 2011 |
| Last Updated: | July 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Lymphoma Lymphoma, Non-Hodgkin Waldenstrom Macroglobulinemia Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoma, B-Cell, Marginal Zone Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |