O6-Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cell in Treating Patients With Malignant Gliomas

Summary

This phase I/II trial studies the side effects and best dose of temozolomide when given together with radiation therapy, carmustine, O6-benzylguanine, and patients' own stem cell (autologous) transplant in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma. Giving chemotherapy, such as temozolomide, carmustine, and O6-benzylguanine, and radiation therapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or plerixafor, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D conformal IMRT

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous in vitro-treated peripheral blood stem cell transplant

DRUG

Carmustine

Given IV

BIOLOGICAL

Filgrastim

Given SC

PROCEDURE

In Vitro-Treated Peripheral Blood Stem Cell Transplantation

Undergo autologous in vitro-treated peripheral blood stem cell transplant

RADIATION

Intensity-Modulated Radiation Therapy

Undergo 3D conformal IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

O6-Benzylguanine

Given IV

DRUG

Plerixafor

Given SC

RADIATION

Proton Beam Radiation Therapy

Undergo proton beam radiation therapy

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Hans-Peter Kiem · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-25

Primary Completion

2018-07-06

Completion

2021-01-20

Countries

• United States

Study Locations