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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute Dynavax Technologies Corporation James P. Wilmot Cancer Center University of Rochester Brigham and Women's Hospital Massachusetts General Hospital |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00251394 |
Purpose
The main purpose of this study is to determine the effects (good and bad) and the safety of Dynavax's immunostimulatory phosphorothiolate oligodeoxyribonucleotide (1018 ISS) given in combination with Rituxan on patients with B-cell follicular non-Hodgkin's lymphoma. This research is being done because recurrent follicular non-Hodgkin's lymphoma is not curable with standard chemotherapy or antibody treatments. 1018 ISS is an experimental compound that consists of short pieces of DNA that stimulate the immune system. It is hoped that 1018 ISS may improve the ability of Rituxan to kill cancer cells.
| Condition | Intervention | Phase |
|
Non-Hodgkin's Lymphoma |
Drug: Rituxan Drug: 1018 ISS |
Phase II |
| MedlinePlus related topics: | Cancer Lymphoma |
| ChemIDplus related topics: | Rituximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2, Open-Label Study of the Efficacy, Safety, and Tolerability of Dynavax's Immunostimulatory Phosphorothiolate Oligodeoxyribonucleotide, 1018 ISS, Following Rituxan (Rituximab) Treatment in Patients With CD20+, B-Cell Follicular Non-Hodgkin's Lymphoma. |
| Enrollment: | 30 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2006 (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:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |||||
| Dana-Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| Brigham and Women's Hospital | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| Massachusetts General Hospital | |||||
| Boston, Massachusetts, United States, 02114 | |||||
| Dana-Farber Cancer Institute |
| Dynavax Technologies Corporation |
| James P. Wilmot Cancer Center |
| University of Rochester |
| Brigham and Women's Hospital |
| Massachusetts General Hospital |
| Principal Investigator: | Arnold Freedman, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Dana-Farber Cancer Institute ( Arnold Freedman, MD ) |
| Study ID Numbers: | 03-411, R21, U10402 |
| First Received: | November 8, 2005 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00251394 |
| Health Authority: | United States: Food and Drug Administration |
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