A Phase I Study of AMG 386 (IND#114215), An Angiopoietin Neutralizing Peptibody, In Children With Relapsed or Refractory Solid Tumors, Including CNS Tumors (ADVL1115)

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Research

Protocol

ADV1115: A Phase I Study of AMG 386 (IND#114215), An Angiopoietin Neutralizing Peptibody, In Children With Relapsed or Refractory Solid Tumors, Including CNS Tumors (ADVL1115)

Diseases

Phase I Studies : Relapsed or refractory solid tumors, including CNS tumors

Description

This is a phase I study of a new drug, AMG 386. This drug is a in a class of drugs called angiopoietin neutralizing peptibodies, which is thought to work by regulating blood vessel growth of tumors by inhibiting the angiopoietin pathway. Part 1 will include children with non-CNS solid tumors that have failed previous treatment(s). Part 1 will be done to find the highest safe dose (called the “maximum tolerated dose or MTD”). Part 2 will evaluate the MTD in children with CNS tumors that are refractory (do not respond to treatment) or recurrent (come back). AMG 386 is given by weekly IV infusion. Biology and x-ray research studies are also performed. This study will last 5 years.

Objectives

To find the highest safe dose (MTD) of AMG386 that can be given without causing severe side effects in children with recurrent solid tumors.
To learn what kind of side effects AMG 386 can cause.
To learn more about how the body handles AMG386.
To learn more about the effect of AMG 386 on blood flow in the tumor by using special imaging device called Magnetic Resonance Imaging (MRI).
To determine whether AMG386 is a beneficial treatment for these kinds of tumors.
To determine if children with recurrent CNS tumors can tolerate the same “MTD” of AMG386 as children with recurrent solid tumors.

Eligibility criteria, among others, include:

Participant is > 12 months and < 21years of age at the time of study enrollment.
Participant has either measurable or evaluable disease.
Participant has fully recovered from any side effects of prior anti-cancer therapy.
Participant has no known cardiac disease.
Participant does not have evidence of active bleeding.
Participant is not currently receiving other anti-cancer agents.

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 Information

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.

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