Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma - Full Text View

Sponsored by:	Biovest International
Information provided by:	Biovest International
ClinicalTrials.gov Identifier:	NCT00091676

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: tumor specific immune response Biological: control vaccine	Phase III

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:

Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission

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:

February 2000

Estimated Study Completion Date:

March 2009

Estimated Primary Completion Date:

March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: tumor specific immune response 5 vaccinations over a 6 month time period
2: Active Comparator	Biological: control vaccine 5 vaccinations over a 6 month time period

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