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| Sponsored by: |
Genitope Corporation |
| Information provided by: | Genitope Corporation |
| ClinicalTrials.gov Identifier: | NCT00510471 |
Purpose
The treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together with the personalized active immunotherapy because it may increase the immune system's response and, therefore, aid in the effect of the personalized active immunotherapy.
This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile have been seen to date in these studies.
| Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine |
Phase II |
| MedlinePlus related topics: | Cancer Lymphoma |
| ChemIDplus related topics: | Rituximab Sargramostim Granulocyte-macrophage colony-stimulating factor Immunoglobulins Globulin, Immune |
| Study Type: | Interventional |
| Study Design: | Open Label, Active Control, Single Group Assignment |
| Official Title: | A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo) |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, California | |||||
| Keck School of Medicine of University Southern California | |||||
| Los Angeles, California, United States, 90089 | |||||
| United States, Colorado | |||||
| Rocky Mountain Cancer Centers | |||||
| Denver, Colorado, United States, 80218 | |||||
| United States, Indiana | |||||
| Indiana University Medical Center | |||||
| Indianapolis, Indiana, United States, 46202 | |||||
| United States, Massachusetts | |||||
| Dana-Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| United States, Nebraska | |||||
| University of Nebraska Medical Center | |||||
| Omaha, Nebraska, United States, 68198-7680 | |||||
| United States, New York | |||||
| Weill Medical College of Cornell University, NY Presbyterian Hospital | |||||
| New York, New York, United States, 10021 | |||||
| United States, North Carolina | |||||
| Carolinas Medical Center | |||||
| Charlotte, North Carolina, United States, 28204 | |||||
| United States, Oklahoma | |||||
| University of Oklahoma Health Science Center | |||||
| Oklahoma City, Oklahoma, United States, 73174 | |||||
| United States, Oregon | |||||
| Providence Portland Cancer Center | |||||
| Portland, Oregon, United States, 97213 | |||||
| Genitope Corporation |
More Information
Click here for more information for untreated patients with follicular Non-Hodgkin's lymphoma who require treatment
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| Study ID Numbers: | 2007-12 |
| First Received: | July 31, 2007 |
| Last Updated: | March 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00510471 |
| Health Authority: | United States: Food and Drug Administration |
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