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Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma (BiovaxID)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Biovest International.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00091676
First Posted: September 17, 2004
Last Update Posted: February 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
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 Intervention Phase
Non-Hodgkins Lymphoma Biological: FNHLId1 Biological: KLH + GM-CSF Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Resource links provided by NLM:


Further study details as provided by Biovest International:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To determine the ability of the idiotype vaccine to produce a molecular complete remission [ Time Frame: once subject achieves molecular CR ]
  • To determine the impact of molecular disease free survival [ Time Frame: until relapse ]
  • To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor [ Time Frame: varies ]
  • To compare the overall survival of subjects randomized to receive either treatment [ Time Frame: minimum 5 years from last subject randomized ]
  • To confirm the safety of 5 monthly injections of the vaccine with GM-CSF [ Time Frame: 4 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091676


Sponsors and Collaborators
Biovest International
Investigators
Study Director: Carlos F Santos, PhD Biovest International
Principal Investigator: Stephen J Schuster, MD University of Pennsylvania
  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
First Submitted: September 15, 2004
First Posted: September 17, 2004
Last Update Posted: February 3, 2012
Last Verified: February 2012

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
Vaccines
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs