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

Sponsor:	Biovest International
Information provided by (Responsible Party):	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: FNHLId1 Biological: KLH + GM-CSF	Phase III

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:

MedlinePlus related topics: Cancer Lymphoma

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

U.S. FDA Resources

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

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Schuster SJ, Neelapu SS, Gause BL, Janik JE, Muggia FM, Gockerman JP, Winter JN, Flowers CR, Nikcevich DA, Sotomayor EM, McGaughey DS, Jaffe ES, Chong EA, Reynolds CW, Berry DA, Santos CF, Popa MA, McCord AM, Kwak LW. Vaccination with patient-specific tumor-derived antigen in first remission improves disease-free survival in follicular lymphoma. J Clin Oncol. 2011 Jul 10;29(20):2787-94. Epub 2011 May 31.

Hsu FJ, Caspar CB, Czerwinski D, Kwak LW, Liles TM, Syrengelas A, Taidi-Laskowski B, Levy R. Tumor-specific idiotype vaccines in the treatment of patients with B-cell lymphoma--long-term results of a clinical trial. Blood. 1997 May 1;89(9):3129-35.

Bendandi M, Gocke CD, Kobrin CB, Benko FA, Sternas LA, Pennington R, Watson TM, Reynolds CW, Gause BL, Duffey PL, Jaffe ES, Creekmore SP, Longo DL, Kwak LW. Complete molecular remissions induced by patient-specific vaccination plus granulocyte-monocyte colony-stimulating factor against lymphoma. Nat Med. 1999 Oct;5(10):1171-7.

Kwak LW, Campbell MJ, Czerwinski DK, Hart S, Miller RA, Levy R. Induction of immune responses in patients with B-cell lymphoma against the surface-immunoglobulin idiotype expressed by their tumors. N Engl J Med. 1992 Oct 22;327(17):1209-15.

Dar MM, Kwak LW. Vaccination strategies for lymphomas. Curr Oncol Rep. 2003 Sep;5(5):380-6. Review.

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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012