Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma (BiovaxID)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 | Intervention | Phase |
|---|---|---|
|
Non-Hodgkins Lymphoma |
Biological: FNHLId1 Biological: KLH + GM-CSF |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission |
- To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients [ Time Frame: until date of relapse ] [ Designated as safety issue: Yes ]
- To determine the ability of the idiotype vaccine to produce a molecular complete remission [ Time Frame: once subject achieves molecular CR ] [ Designated as safety issue: No ]
- To determine the impact of molecular disease free survival [ Time Frame: until relapse ] [ Designated as safety issue: No ]
- To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor [ Time Frame: varies ] [ Designated as safety issue: No ]
- To compare the overall survival of subjects randomized to receive either treatment [ Time Frame: minimum 5 years from last subject randomized ] [ Designated as safety issue: No ]
- To confirm the safety of 5 monthly injections of the vaccine with GM-CSF [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 629 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ID-KLH + GM-CSF |
Biological: FNHLId1
5 monthly vaccinations over a 6 month time period consisting of 0.5 mg ID-KLH s.c. on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4
|
| Active Comparator: KLH + GM-CSF |
Biological: KLH + GM-CSF
5 monthly vaccinations at month 1, 2, 3, 4, and 6 consisting of 0.5 mg KLH s.c on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4
|
Detailed Description:
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 or CHOP-R 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 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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion/Exclusion Criteria:
- Diagnosis of indolent follicular lymphoma(follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes) with surface IgM or IgG phenotype.
- Stage III-IV with lymph node > 2cm or Stage II with lymph node > 5 cm
- No prior chemotherapy other than local radiation (not greater than 2 sites)
- ECOG < 2
- Survival > 1 yr
- Serum creatinine < 1.5 mg/dl
- Bilirubin <1.5 mg/dl
- SGOT/SGPT < 3.5 ULN
- No HIV antibodies or HBV antigen
- Negative pregnancy screen (females)
- No unrelated neoplasm in the previous 10 years
- No evidence of primary or secondary CNS lymphoma
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Biovest International |
| ClinicalTrials.gov Identifier: | NCT00091676 History of Changes |
| Obsolete Identifiers: | NCT00001945, NCT00019981, NCT00096577 |
| Other Study ID Numbers: | BV 301 |
| Study First Received: | September 15, 2004 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biovest International:
|
follicular lymphoma Non-Hodgkins idiotype vaccine |
indolent follicular Non-Hodgkins Lymphoma tumor-derived B-cell cancer |
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 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013