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Sponsored by: |
Genitope Corporation |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00071955 |
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase II trial to study the effectiveness of rituximab followed by vaccine therapy and sargramostim in treating patients who have refractory or progressive 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: | A Phase II Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH and GM-CSF Following the Anti-CD20 Antibody, Rituximab, in Previously Treated Patients With Follicular Non-Hodgkin's Lymphoma |
Study Start Date: | March 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study for patients previously registered on and confirmed ineligible for randomization in protocol Genitope-G2000-03.
Patients receive rituximab IV weekly for 4 weeks.
Patients are followed for initial response 8 weeks after completion of immunizations and then every 12 weeks for an additional year. Thereafter, all immunized patients will be followed every 6 months until receipt of first subsequent anti-lymphoma therapy.
PROJECTED ACCRUAL: Up to 120 patients 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:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent chronic (more than twice monthly) corticosteroids (including topical or inhaled)
Radiotherapy
Surgery
Other
United States, California | |
Stanford Cancer Center at Stanford University Medical Center | |
Stanford, California, United States, 94305-5151 | |
United States, Illinois | |
Rush Cancer Institute at Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-7680 | |
United States, New York | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 | |
United States, Oregon | |
Cancer Institute at Oregon Health and Science University | |
Portland, Oregon, United States, 97201-3098 | |
Canada, Alberta | |
Cross Cancer Institute at University of Alberta | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, Ontario | |
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 |
Study Chair: | Martha Mayo, PharmD | Genitope Corporation |
Study ID Numbers: | CDR0000269810, GENITOPE-2002-09, IUMC-0212-20 |
Study First Received: | November 4, 2003 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00071955 History of Changes |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma |
stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma |
Immunoproliferative Disorders Immunologic Factors Immunoglobulin Idiotypes Rituximab Lymphoma, Follicular Follicular Lymphoma Recurrence |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Antibodies Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunoglobulin Idiotypes Immunologic Factors Physiological Effects of Drugs Lymphoma, Follicular |
Pharmacologic Actions Lymphatic Diseases Neoplasms Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |