Finding studies
Finding studies
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Lead
Morphotek
With
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of MORAb-004 (anti-endosialin/TEM1 monoclonal antibody MORAb-004) administered as an intravenous infusion every week to children with refractory solid tumors. II. To define and describe the toxicities of MORAb-004 administered on this schedule. III. To characterize the pharmacokinetics of MORAb-004 in children with refractory cancer. IV. To monitor for the development of human anti-human antibody (HAHA) in children receiving MORAb-004. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of MORAb-004 within the confines of a phase 1 study. II. To examine tumor endothelial marker-1 (TEM-1) and PDGFRB levels in tissue and plasma samples as potential biomarkers of MORAb-004 activity. III. To correlate baseline expression of TEM-1 and PDGFRB (in issue and plasma)with clinical parameters including disease response in an exploratory manner. OUTLINE: This is a dose escalation study. Patients receive anti-endosialin/TEM1 monoclonal antibody MORAb-004 intravenously (IV) on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
