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BG & TMZ Therapy of Glioblastoma Multiforme

NCT01269424 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-02

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. O6-benzylguanine may help temozolomide work better by making tumor cells more sensitive to the drug. Giving genetically modified peripheral blood stem cells during or after treatment may prevent side effects caused by chemotherapy.

PURPOSE: This clinical trial studies O6-benzylguanine and temozolomide in combination with genetically modified peripheral blood stem cells in treating patients with newly diagnosed glioblastoma multiforme.

Conditions

Interventions

BIOLOGICAL

MGMTP140K-encoding retroviral vector

DRUG

O6-benzylguanine

DRUG

temozolomide

OTHER

laboratory biomarker analysis

PROCEDURE

autologous hematopoietic stem cell transplantation

PROCEDURE

in vitro-treated peripheral blood stem cell transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Stanton Gerson MD

    lead OTHER

Principal Investigators

  • Andrew Sloan, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-22
Primary Completion
2020-12-07
Completion
2022-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269424 on ClinicalTrials.gov