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| Sponsor: | Genitope Corporation |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00071955 |
Purpose
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.
In all groups, treatment continues in the absence of unacceptable toxicity or emergence of an illness that may interfere with study assessments.
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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| 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 |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunoglobulin Idiotypes Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Lymphoma, Follicular |
Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |