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Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients with Follicular Lymphoma
This study is currently recruiting patients.
| Sponsored by: | Biovest International |
|---|---|
| Information provided by: | Biovest International |
Purpose
The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Non-Hodgkins Lymphoma |
Vaccine: tumor specific immune response |
Phase III |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Trial of Patient Specific Vaccination in First Complete Remission with Conjugated Follicular Lymphoma-Derived Idiotype with Local GM-CSF
Primary Outcomes: To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission)
in idiotype vaccine treated patients
Secondary Outcomes: To determine the ability of the idiotype vaccine to produce a molecular complete remission; To determine the impact of molecular disease free survival; To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor; To compare the overall survival of subjects randomized to receive either treatment; To confirm the safety of 5 monthly injections of the vaccine with GM-CSF
Expected Total Enrollment: 563
Study start: February 2000
Patients with Stage III-IV follicular lymphoma and tumor > 2cm (Stage II allowed if tumor > 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 monthly idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Location
and Contact
Information
More Information
Publications
Dar MM, Kwak LW. Vaccination strategies for lymphomas. Curr Oncol Rep. 2003 Sep;5(5):380-6. Review.
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