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A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma

Phase 3
18 Years
Not Enrolling
Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System

Thank you

Trial Information

A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma


- Compare the overall survival, failure-free survival, and progression-free survival of
patients with newly diagnosed glioblastoma multiforme or gliosarcoma treated with
radiotherapy and carmustine with or without O6-benzylguanine.

- Compare the frequency and severity of toxic effects of these regimens in these

- Correlate the survival of these patients with the expression of O6-alkylguanine-DNA

OUTLINE: This is a randomized study. Patients are stratified according to age (under 50 vs
50 and over), prior surgery (biopsy only vs resection), and Zubrod performance status (0-1
vs 2). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy daily 5 days a week over 7 weeks for a total of 34
fractions. Patients also receive chemotherapy comprising O6-benzylguanine IV over 1
hour followed 6 hours later by carmustine IV over 1 hour on day 1 of radiotherapy.
Chemotherapy repeats every 6 weeks for a maximum of 7 courses in the absence of disease
progression or unacceptable toxicity.

- Arm II: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV as in
arm I.

Patients are followed at week 48, every 4 months for 1 year, and then every 6 months for 4

PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study within 5 years.

Inclusion Criteria


- Histologically confirmed glioblastoma multiforme or gliosarcoma

- Biopsy or surgical resection within the past 28 days

- MRI* with gadolinium performed before registration

- Patients who undergo a simple biopsy only require preoperative MRI* with

- No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)*

- No prior radiotherapy-delivered cephalad to the interspace between the seventh
cervical and the first thoracic vertebral body NOTE: *If an MRI is not medically
feasible, patients may have a CT scan with contrast



- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8 g/dL


- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT/SGPT no greater than 2 times ULN

- Alkaline phosphatase no greater than 2 times ULN

- PT/PTT no greater than 1.2 times ULN


- Not specified


- No severe cardiac disease, including any of the following:

- Uncontrolled arrhythmias or conduction defects

- Major problems with edema (e.g., residual swelling in the legs from deep vein

- Recent coronary artery disease

- Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110
mm Hg and/or systolic blood pressure greater than 180 mm Hg)


- DLCO at least 70% of predicted

- No severe pulmonary disease


- HIV negative

- No severe Cushing's syndrome

- No known allergies to any of the study drugs

- No major psychiatric illness

- No poorly controlled diabetes complicated by steroid treatment

- No other medical illness that cannot be adequately controlled or that would preclude
study participation

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- No prior chemotherapy

- No other concurrent antitumor chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except postmenopausal estrogen replacement therapy

- Corticosteroids at stable or decreasing dose for tumor edema allowed


- See Disease Characteristics

- No prior radiotherapy

- No other concurrent radiotherapy (including intensity-modulated radiotherapy) to the
index lesion(s)


- See Disease Characteristics

- No concurrent antitumor surgery


- No other concurrent investigational drugs

- No other concurrent antineoplastic drugs or therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5

Safety Issue:


Principal Investigator

Deborah T. Blumenthal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Utah


United States: Federal Government

Study ID:




Start Date:

September 2001

Completion Date:

November 2012

Related Keywords:

  • Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Neoplasms
  • Eye Neoplasms
  • Glioblastoma
  • Gliosarcoma



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