Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Study of the TEM-1 Antibody, MORAb-004 (IND# 103821), in Children With Recurrent or Refractory Solid Tumors
This phase I trial studies the side effects and best dose of MORAb-004 in treating young patients with recurrent or refractory solid tumors or lymphoma. Monoclonal antibodies, such as MORAb-004, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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