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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 because the information has not been verified recently.
Verified February 2012 by Biovest International.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Biovest International
ClinicalTrials.gov Identifier:
NCT00091676
First received: September 15, 2004
Last updated: February 1, 2012
Last verified: February 2012
  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

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014