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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)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Biovest International

Tracking Information
First Submitted Date  ICMJE September 15, 2004
First Posted Date  ICMJE September 17, 2004
Last Update Posted Date February 3, 2012
Study Start Date  ICMJE January 2000
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients
Change History Complete list of historical versions of study NCT00091676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma
Official Title  ICMJE Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkins Lymphoma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: ID-KLH + GM-CSF
    Intervention: Biological: FNHLId1
  • Active Comparator: KLH + GM-CSF
    Intervention: Biological: KLH + GM-CSF
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 11, 2007)
629
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
563
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00091676
Other Study ID Numbers  ICMJE BV 301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biovest International
Study Sponsor  ICMJE Biovest International
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carlos F Santos, PhD Biovest International
Principal Investigator: Stephen J Schuster, MD University of Pennsylvania
PRS Account Biovest International
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP