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

Non-Hodgkins Lymphoma Clinical Trial

— BiovaxID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00091676
• Other study ID #: BV 301
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 15, 2004
• Last updated: February 1, 2012
• Start date: January 2000
• Est. completion date: December 2012

Study information

• Verified date: February 2012
• Source: Biovest International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00001945
• NCT00019981
• NCT00096577

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 629
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biovest International

References & Publications (5)

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. — View Citation

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

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. — View Citation

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. — View Citation

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 tum — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients		until date of relapse	Yes
Secondary	To determine the ability of the idiotype vaccine to produce a molecular complete remission		once subject achieves molecular CR	No
Secondary	To determine the impact of molecular disease free survival		until relapse	No
Secondary	To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor		varies	No
Secondary	To compare the overall survival of subjects randomized to receive either treatment		minimum 5 years from last subject randomized	No
Secondary	To confirm the safety of 5 monthly injections of the vaccine with GM-CSF		4 days	Yes

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