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Sponsored by: |
University of California, Davis |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00009776 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with cyclosporine and paclitaxel may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy combined with paclitaxel and cyclosporine in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: cyclosporine Drug: indium In 111 monoclonal antibody Lym-1 Drug: monoclonal antibody Lym-1 Drug: paclitaxel Drug: yttrium Y 90 monoclonal antibody Lym-1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Combined Modality Radioimmunotherapy For Non-Hodgkin's Lymphoma With Three Cycles Of 90Y-DOTA-Peptide-Lym-1, Paclitaxel and Cyclosporin A |
Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody Lym-1 (Y90 MOAB Lym-1).
Patients receive oral cyclosporine every 12 hours on days -2 to 14. Patients receive unlabeled MOAB Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 IV on day 0. On day 7, patients receive unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV. Patients in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9. Courses repeat every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of Y90 MOAB Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months, every 3 months for 21 months, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 36 months.
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:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, California | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95816 |
Study Chair: | Gerald L. DeNardo, MD | University of California, Davis |
Study ID Numbers: | CDR0000068371, UCD-991869, NCI-V00-1641 |
Study First Received: | February 2, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00009776 |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma |
recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Cyclosporine Clotrimazole Miconazole Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Cyclosporins Lymphoma, large-cell, immunoblastic Antibodies, Monoclonal Lymphoma, B-Cell Lymphoma, large-cell Burkitt's lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic |
Lymphoma Immunoglobulins Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Tioconazole Lymphoblastic lymphoma Mantle cell lymphoma Recurrence Lymphatic Diseases Antibodies Paclitaxel Burkitt Lymphoma B-cell lymphomas |
Anti-Infective Agents Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Antifungal Agents Therapeutic Uses Tubulin Modulators Antirheumatic Agents Antineoplastic Agents, Phytogenic Dermatologic Agents |