Protocol

ADV1213: A Phase I Study of the TEM-1 Antibody, MORAb-004 (IND# 103821) in Children with Relapsed or Refractory Solid Tumors (ADVL1213)

Diseases

Solid Tumor : Relapsed or refractory solid tumors

Description

This is a Phase 1 study of a drug called MORAb-004. MORAb-004 is experimental because it has not been approved by the Food and Drug Administration (FDA). This is called a Phase 1 study because the goal is to find the highest dose MORAb-004 that we can give safely. The physicians are using MORAb-004 because it seems to work against cancer in test tubes and animals. They do not know if MORAb-004 will work in children with cancer.

The study drug, MORAb-004, will be given as an intravenous infusion over 30 minutes to 2½ hours, once a week for 4 weeks. Some patients may not tolerate a fast rate of MORAb-004 and may need a longer infusion, sometimes up to 6 or 7 hours. This entire four week period is called a cycle.

Different doses of the study drug, MORAb-004, will be given to several study participants. The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered.


Objectives


Eligibility criteria, among others, include:

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).


Contact

Wayne Furman, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
FAX: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.