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Trial record 1 of 1 for:    BioVaxID
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Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma (BiovaxID)

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. Identifier: NCT00091676
Recruitment Status : Unknown
Verified February 2012 by Biovest International.
Recruitment status was:  Active, not recruiting
First Posted : September 17, 2004
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):
Biovest International

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Hodgkins Lymphoma Biological: FNHLId1 Biological: KLH + GM-CSF Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 629 participants
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
Study Start Date : January 2000
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Vaccines

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. To determine the ability of the idiotype vaccine to produce a molecular complete remission [ Time Frame: once subject achieves molecular CR ]
  2. To determine the impact of molecular disease free survival [ Time Frame: until relapse ]
  3. To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor [ Time Frame: varies ]
  4. To compare the overall survival of subjects randomized to receive either treatment [ Time Frame: minimum 5 years from last subject randomized ]
  5. To confirm the safety of 5 monthly injections of the vaccine with GM-CSF [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT00091676

Sponsors and Collaborators
Biovest International
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Study Director: Carlos F Santos, PhD Biovest International
Principal Investigator: Stephen J Schuster, MD University of Pennsylvania
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Biovest International Identifier: NCT00091676    
Obsolete Identifiers: NCT00001945, NCT00019981, NCT00096577
Other Study ID Numbers: BV 301
First Posted: September 17, 2004    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012
Keywords provided by Biovest International:
indolent follicular Non-Hodgkins Lymphoma
Additional relevant MeSH terms:
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Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases