Clinical Trials Directory

Trials / Completed

CompletedNCT01748721

MORAb-004 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma

Study of the TEM-1 Antibody, MORAb-004 (IND# 103821), in Children With Recurrent or Refractory Solid Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
27 (actual)
Sponsor
Morphotek · Industry
Sex
All
Age
13 Months – 21 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALanti-endosialin/TEM1 monoclonal antibody MORAb-004Given IV
OTHERpharmacological studyCorrelative studies
OTHERlaboratory biomarker analysisOptional correlative studies

Timeline

Start date
2013-11-01
Primary completion
2015-05-01
Completion
2015-05-01
First posted
2012-12-12
Last updated
2016-01-08

Locations

20 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01748721. Inclusion in this directory is not an endorsement.