Monoclonal Antibody Therapy in Treating Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT00003082|
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : March 16, 2010
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibodies in treating patients who have advanced cancer.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific||Biological: monoclonal antibody A27.15 Biological: monoclonal antibody E2.3||Phase 1|
OBJECTIVES: I. Determine the toxicities associated with a 4-hour infusion of antitransferrin receptor antibodies with one antibody administered by itself for 1 hour before the second antibody infusion is started. II. Determine the pharmacokinetics of monoclonal antibodies E2.3 and A27.15.
OUTLINE: This is a dose escalating study. Patients receive antitransferrin antibody A27.15 IV over 4 hours. One hour after the initiation of the A27.15 infusion, infusion of antibody E2-3 is added by IV piggy back. In the absence of antimouse antibodies and toxic effects, treatment continues once every 4 weeks in patients achieving minimal, partial, or complete remission. Treatment ceases in patients experiencing stable or progressive disease. In the absence of dose limiting toxicity in the first 3 patients treated, subsequent cohorts of 6 patients each receive escalating doses of antitransferrin antibodies E2.3 and A27.15 on the same dose schedule. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the MTD. Patients are followed for 3 weeks.
PROJECTED ACCRUAL: This study will accrue 18-27 patients within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Official Title:||A Phase IA Trial of Combined Murine IgG Monoclonal Anti-Transferrin Receptor Antibodies E2.3 and A27.15 in Cancer Patients|
|Study Start Date :||December 1997|
|Primary Completion Date :||February 2001|
|Study Completion Date :||February 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003082
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|Study Chair:||Michael Lobell, MD||University of Arizona|