Clinical Trial: MORAb-004 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study of the TEM-1 Antibody, MORAb-004 (IND# 103821), in Children With Recurrent or Refractory Solid Tumors
Brief 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 Summary:
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.
Sponsor: Morphotek
Current Primary Outcome:
- 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 [ Time Frame: Up to 3 years ]A descriptive summary of all toxicities will be reported.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Morphotek
Dates:
Date Received: December 11, 2012
Date Started: November 2013
Date Completion:
Last Updated: January 7, 2016
Last Verified: December 2015
