Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma
This study has been terminated.
Sponsor:
Genitope Corporation
Information provided by:
Genitope Corporation
ClinicalTrials.gov Identifier:
NCT00510471
First received: July 31, 2007
Last updated: March 14, 2008
Last verified: March 2008
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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 |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| 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) |
Resource links provided by NLM:
Further study details as provided by Genitope Corporation:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent
- Previously untreated follicular NHL
- Stage III or IV disease requiring treatment
- Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin)
- Able to provide tumor sample adequate for Id-KLH manufacture
- ≥ 18 years of age
- At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510471
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 | |
Sponsors and Collaborators
Genitope Corporation
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00510471 History of Changes |
| Other Study ID Numbers: | 2007-12 |
| Study First Received: | July 31, 2007 |
| Last Updated: | March 14, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Immunoglobulin Idiotypes |
Immunoglobulins Antibodies Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013