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

Conditions

• Recurrent Childhood Brain Tumor

Eligibility Criteria

Sex

ALL

Age

1 Month - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Tumor biology testing — DEVICE
  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.
• Temozolomide — DRUG
  Temozolomide combined with Etoposide is considered the "best available" combination of low-dose oral cytotoxic agents for patients with refractory or recurrent CNS tumors.
• Etoposide — DRUG
  Etoposide combined with Temozolomide is considered the "best available" combination of low-dose oral cytotoxic agents for patients with refractory or recurrent CNS tumors.
• Sorafenib — DRUG
  Sorafenib is a broad-spectrum kinase inhibitor.
• Everolimus — DRUG
  Everolimus is an mTOR pathway inhibitor.
• Erlotinib — DRUG
  Erlotinib is a tyrosine kinase inhibitor of the ERBB family of proteins.
• Dasatinib — DRUG
  Dasatinib is a broad spectrum SRC inhibitor.

Study Details

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.

Key Dates

First listed

Dec 19, 2013

Start date

Dec 31, 2013

Status verified

Dec 2016

Primary completion

Nov 30, 2016

Completion

Dec 31, 2017

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Regimen B
  Depending on tumor biology testing, subjects assigned to Regimen B will receive: Temozolomide 150 mg/m2/dose daily PO on days 1-5, Etoposide 50 mg/m2/dose daily PO on days 1-12, and Everolimus 3 mg/m2/dose daily PO on days 1-28. Cycles will be repeated every 28 days for up to 12 cycles.
• Experimental: Regimen C
  Depending on tumor biology testing, subjects assigned to Regimen C will receive: Temozolomide 150 mg/m2/dose daily PO on days 1-5, Etoposide 50 mg/m2/dose daily PO on days 1-12, and Erlotinib 85 mg/m2/dose daily PO on days 1-28. Cycles will be repeated every 28 days for up to 12 cycles.
• Experimental: Regimen D
  Depending on tumor biology testing, subjects assigned to Regimen D will receive: Temozolomide 150 mg/m2/dose daily PO on days 1-5, Etoposide 50 mg/m2/dose daily PO on days 1-12, and Dasatinib 60 mg/m2/dose BID PO on days 1-28. Cycles will be repeated every 28 days for up to 12 cycles.
• Experimental: Regimen A
  Depending on tumor biology testing, subjects assigned to Regimen A will receive: Temozolomide 150 mg/m2/dose daily PO on days 1-5, Etoposide 50 mg/m2/dose daily PO on days 1-12, and Sorafenib 150 mg/m2/dose BID PO on days 1-28. Cycles will be repeated every 28 days for up to 12 cycles.

Primary Outcome Measure

Feasibility [ Time Frame: 3 years ]

Locations (1)

Find similar trials in Seattle, WA

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