Phase I Study of Bevacizumab and Sorafenib Combined with Low Dose Cyclophosphamide in Patients with Refractory Solid Tumors and Leukemia

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Research

Protocol

ANGIO1: Phase I Study of Bevacizumab and Sorafenib Combined with Low Dose Cyclophosphamide in Patients with Refractory Solid Tumors and Leukemia

Diseases

Solid Tumor : Recurrent or refractory solid tumors and leukemias

Description

This research is being done to find new and more effective treatments against childhood cancers. The children enrolled in this study have a solid tumor or leukemia that has either come back (relapsed) or did not respond to treatment (refractory) or there is no therapy known to be effective.

The purpose of this study is to find the largest dose of sorafenib and bevacizumab in combination with low dose cyclophosphamide that can be given safely to children and young adults with solid tumors and leukemia. This study combines three drugs that are thought to work on tumors by affecting the blood vessels in the tumor. We have recently identified a dose of the combination of these drugs that appears to be safe to use in children with solid tumors. We are now treating children with relapsed or refractory solid tumor or leukemia at these doses to better understand the side effects of these drugs when they are given together.

Objectives

To learn the highest safe dose of two new drugs called sorafenib and bevacizumab that we can give with another cancer drug called cyclophosphamide
To learn the effects (good or bad) of these drugs working together and the side effects they cause

Eligibility

Participant under the age of 22 at time of initial diagnosis
Participant does not have clinical evidence of CNS disease
Participant must have adequate organ and bone marrow function
Participants must have fully recovered from acute toxic effects of all prior therapy prior to enrolling on study
Participants with a body surface area less than 0.3m² will not be eligible for this study
Participants with known hypersensitivity to other recombinant human antibodies will not be eligible for this study
Participants who have an uncontrolled infection will not be eligible for this study

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

Fariba Navid, 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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