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A Phase I/II Trial of Conformal Radiotherapy and Hyperbaric Oxygen for Patients With Newly Diagnosed Glioblastoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

A Phase I/II Trial of Conformal Radiotherapy and Hyperbaric Oxygen for Patients With Newly Diagnosed Glioblastoma


OBJECTIVES: I. Determine the feasibility and toxicity of hyperbaric oxygen combined with
conformal radiotherapy in patients with newly diagnosed glioblastoma multiforme. II.
Determine the efficacy of this regimen in terms of radiographic tumor response, time to
tumor progression, and survival in these patients.

OUTLINE: Within 2 weeks after surgery, patients receive hyperbaric oxygen over 90 minutes
once daily, followed by conformal radiotherapy twice daily 5 days a week for 17 days in the
absence of unacceptable toxicity. Patients are followed within 2 weeks and then every 2
months thereafter.

PROJECTED ACCRUAL: A total of 5-10 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven newly diagnosed glioblastoma multiforme
Measurable residual tumor by MRI after biopsy or craniotomy

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life
expectancy: More than 8 weeks Hematopoietic: Not specified Hepatic: Not specified Renal:
Not specified Pulmonary: No severe pulmonary disease (e.g., emphysema with carbon dioxide
retention) No untreated pneumothorax Other: Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception No other malignancy within the past
5 years except epithelial skin cancer No psychological, familial, sociological, or
geographical conditions that would preclude study No intractable seizure disorder

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or
concurrent bleomycin Endocrine therapy: Not specified Radiotherapy: No prior cranial
radiotherapy Surgery: See Disease Characteristics Other: No other prior therapy, including
adjuvant therapy, for glioblastoma multiforme

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ronald E. Warnick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barrett Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068256

NCT ID:

NCT00006460

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219