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Sponsors and Collaborators: |
Favrille National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104819 |
RATIONALE: Vaccines made from a person's cancer cells may make 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 and may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: sargramostim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06 |
Estimated Enrollment: | 238 |
Study Start Date: | September 2004 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm).
Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4.
Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression.
After completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment.
PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
Meets 1 of the following criteria:
Received salvage therapy after completion of protocol FAV-ID-06
Did not receive salvage therapy after completion of protocol FAV-ID-06
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | John F. Bender, PharmD | Favrille |
Study ID Numbers: | CDR0000415573, FAV-ID-09, CWRU-FVID-2404, CWRU-100415, CASE-2404, FAV-WIRB-20041124 |
Study First Received: | March 3, 2005 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00104819 History of Changes |
Health Authority: | Unspecified |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
Immunoproliferative Disorders Immunoglobulin Idiotypes Immunologic Factors Lymphoma, Follicular Follicular Lymphoma Recurrence Lymphoma, Small Cleaved-cell, Diffuse |
Lymphatic Diseases Antibodies Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immunologic Factors Immunoglobulin Idiotypes |
Immune System Diseases Physiological Effects of Drugs Lymphoproliferative Disorders Lymphoma Pharmacologic Actions Immunoglobulins |