Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma (BiovaxID)

• ClinicalTrials.gov Identifier: NCT00091676
• Recruitment Status: Unknown
• First Posted: September 17, 2004
• Last Update Posted: February 3, 2012
• Sponsor: Biovest International
• Information provided by (Responsible Party): Biovest International

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

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 

Publications of Results:

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. doi: 10.1200/JCO.2010.33.3005. Epub 2011 May 31.

Other Publications:

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. doi: 10.1038/13928.

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. doi: 10.1056/NEJM199210223271705.

Dar MM, Kwak LW. Vaccination strategies for lymphomas. Curr Oncol Rep. 2003 Sep;5(5):380-6. doi: 10.1007/s11912-003-0022-x.

• Responsible Party: Biovest International
• ClinicalTrials.gov Identifier: NCT00091676
• Obsolete Identifiers: NCT00001945, NCT00019981, NCT00096577
• Other Study ID Numbers: BV 301
• First Posted: September 17, 2004
• Last Update Posted: February 3, 2012
• Last Verified: February 2012

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