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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Given IV
Correlative studies
Optional correlative studies
Children's Hospital of Alabama
Birmingham, Alabama, United States
Children's Hospital of Orange County
Orange, California, United States
University of California San Francisco Medical Center - Parnassus
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
University of Minnesota Cancer Center-Fairview
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
...and 10 more locations
MTD, defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicities (DLT) graded according to the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 4 weeks
Incidence of toxicities, graded according to NCI CTCAE version 4.0
A descriptive summary of all toxicities will be reported.
Time frame: Up to 3 years
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