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Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Study NCT00258336   Information provided by National Cancer Institute (NCI)
First Received: November 22, 2005   Last Updated: February 6, 2009   History of Changes

November 22, 2005
February 6, 2009
August 2004
November 2009   (final data collection date for primary outcome measure)
Event-free survival by Kaplan-Meier [ Designated as safety issue: No ]
Event-free survival by Kaplan-Meier
Complete list of historical versions of study NCT00258336 on ClinicalTrials.gov Archive Site
  • Overall response rate (partial and complete response) at month 6 and any time [ Designated as safety issue: No ]
  • Time-to-progression by Kaplan-Meier [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Immune response by cellular or humoral anti-idiotype response positive [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Overall response rate (partial and complete response) at month 6 and any time
  • Time-to-progression by Kaplan-Meier
  • Duration of response
  • Immune response by cellular or humoral anti-idiotype response positive
  • Safety
 
Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma

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.

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.

Phase II
Interventional
Treatment, Open Label
Lymphoma
  • Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine
  • Biological: rituximab
  • Biological: sargramostim
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
56
 
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
 
United States
 
NCT00258336
 
CDR0000449719, FAV-ID-70, FAV-ID-LYM-31
Favrille
 
Study Chair: John F. Bender, PharmD Favrille
National Cancer Institute (NCI)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP