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|
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|