A Phase 1 interventional study of anti-endosialin/TEM1 monoclonal antibody MORAb-004 and pharmacological study in Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by Morphotek. Completed at 20 sites in United States. Open to participants aged 13 Months to 21 Years. Per ClinicalTrials.gov, last updated 2016-01-08.
Sponsored by Morphotek · Phase 1, Interventional, and Treatment
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.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 27 is below the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Morphotek is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70ml/min/1.73 m\^2 OR a serum creatinine based on age/gender as follows:
Exclusion Criteria:
Patients who have had or are planning to have the following invasive procedures are not eligible:
Patients receive anti-endosialin/TEM1 monoclonal antibody MORAb-004 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.
Biological: anti-endosialin/TEM1 monoclonal antibody MORAb-004 · Other: pharmacological study · Other: laboratory biomarker analysis
Given IV
Also known as: MORAb-004
Correlative studies
Also known as: pharmacological studies
Optional correlative studies
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
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Morphotek