Trial | NCT00091676  Report issue

Title

Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma
Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    629
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.
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 Started
Jan 31
2000
Primary Completion
Dec 31
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Feb 03
2012
Estimate

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

ID-KLH + GM-CSF Experimental

KLH + GM-CSF Active Comparator

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
No Results Posted