Selecting Patient-Specific Biologically Targeted Therapy for Pediatric Patients With Refractory Or Recurrent Brain Tumors

Summary

This research study is a Feasibility clinical trial. In this trial, researchers are trying to figure out whether a medication can be chosen based on rapid testing done on tumor tissue. Information from a feasibility or pilot trial will hopefully help researchers plan larger trials in the future to determine the effect of this therapy.

Conditions

• Recurrent Childhood Brain Tumor

Interventions

DEVICE

Tumor biology testing

Tumor biology studies will be performed in a CLIA-approved clinical pathology laboratory using standard procedures. Immunohistochemical (IHC) testing will be performed on formalin fixed tumor obtained at the time of diagnosis and/or relapse. Results will be interpreted by a qualified pediatric pathologist and will be scored on a scale of 0 to 4+ commenting on both percentage of positive cells and intensity of staining. Results will further be reported as a binary result (positive/negative). If more than one tumor specimen is available from different surgical procedures (e.g. initial diagnosis and relapse), the results from the relapse specimen will be prioritized. Results will determine kinase inhibitor treatment arm assignment which will be administered in addition to the "best available" combination of low-dose oral cytotoxic agents, including temozolomide and etoposide.

DRUG

Temozolomide

Temozolomide combined with Etoposide is considered the "best available" combination of low-dose oral cytotoxic agents for patients with refractory or recurrent CNS tumors.

DRUG

Etoposide

Etoposide combined with Temozolomide is considered the "best available" combination of low-dose oral cytotoxic agents for patients with refractory or recurrent CNS tumors.

DRUG

Sorafenib

Sorafenib is a broad-spectrum kinase inhibitor.

DRUG

Everolimus

Everolimus is an mTOR pathway inhibitor.

DRUG

Erlotinib

Erlotinib is a tyrosine kinase inhibitor of the ERBB family of proteins.

DRUG

Dasatinib

Dasatinib is a broad spectrum SRC inhibitor.

Sponsors & Collaborators

• Cures Within Reach

  collaborator OTHER

• Seattle Children's Hospital

  lead OTHER

Principal Investigators

• Sarah ES Leary, MD · Seattle Children's Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Month

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2016-11-30

Completion

2017-12-31

Countries

• United States

Study Locations