Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma

NCT ID: NCT00258336

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with vaccine therapy and GM-CSF may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with vaccine therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

• Determine the efficacy of immunotherapy comprising rituximab, autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™), and sargramostim (GM-CSF), in terms of response rate (partial and complete) and event-free survival, in patients with indolent B-cell non-Hodgkin's lymphoma.
• Determine the safety of this regimen in these patients.
• Evaluate development of an immune response in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

• Induction therapy: Patients receive rituximab IV over 2-4 hours once weekly for 4 weeks. Patients are evaluated for response at month 3. Patients with responding or stable disease proceed to maintenance therapy. Patients with progressive disease are removed from study.
• Maintenance therapy: Patients receive rituximab as in induction therapy in months 7, 13, and 19. Patients also receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) subcutaneously (SC) once on day 1 and sargramostim (GM-CSF) SC once daily on days 1-4 in months 4-6, 8-11, 14, 16, 18, 20, 22, and 24. Patients with continued response after completing 2 years of therapy may continue to receive FavId™ and GM-CSF once every 3 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

autologous immunoglobulin idiotype-KLH conjugate vaccine

Intervention Type: BIOLOGICAL

rituximab

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:

• Grade 1 or 2 follicular lymphoma
• Tumor must be accessible to biopsy or biopsy material available for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™)
• Measurable or evaluable disease after node biopsy
• No mantle cell, marginal zone, MALT-type, small lymphocytic, or grade 3 follicular (follicular large cell) lymphoma
• No CNS involvement with lymphoma

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Platelet count > 100,000/mm^3
• WBC ≥ 3,000/mm^3

Hepatic

• AST and ALT ≤ 2 times upper limit of normal
• Bilirubin ≤ 2 mg/dL

Renal

• Creatinine ≤ 1.5 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after completion of study treatment
• HIV negative
• No other medical or psychiatric disease that would preclude study compliance
• No other malignancy (active or treated) within the past 5 years

PRIOR CONCURRENT THERAPY:

Radiotherapy

• Prior local radiotherapy allowed

Other

• No other prior anticancer therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Favrille

INDUSTRY

Sponsor Role: lead

Principal Investigators

John F. Bender, PharmD

Role: STUDY_CHAIR

Favrille

Locations

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Clinical Trials Office - Sarah Cannon Cancer Center at Centenn

Role: primary

615-329-7274

Other Identifiers

FAV-ID-70

Identifier Type: -

Identifier Source: secondary_id

FAV-ID-LYM-31

Identifier Type: -

Identifier Source: secondary_id

CDR0000449719

Identifier Type: -

Identifier Source: org_study_id