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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00117975 |
RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one monoclonal antibody may be a better way to block cancer growth.
PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: galiximab Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL) |
Estimated Enrollment: | 51 |
Study Start Date: | June 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed every 4 months for up to 10 years.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* previously untreated follicular non-Hodgkin's lymphoma (NHL), meeting 1 of the following stage criteria:
Measurable disease by physical examination or imaging studies
Patients with only nonmeasurable disease are not eligible
The following are considered nonmeasurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
No known HIV positivity
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent dexamethasone or other steroidal antiemetics except for the following circumstances:
Radiotherapy
Surgery
Study Chair: | Myron S. Czuczman, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000433340, CALGB-50402 |
Study First Received: | July 8, 2005 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00117975 |
Health Authority: | United States: Federal Government |
contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II 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 contiguous stage II grade 3 follicular lymphoma |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders Rituximab Lymphoma, small cleaved-cell, diffuse |
Lymphoma, Follicular Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Follicular lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |