Radiation Therapy Plus Hyperbaric Oxygen in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006460

Enrollment

Unknown

Registered

2004-02-03

Start date

2000-08-31

Completion date

Unknown

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Brief summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperbaric oxygen may increase the effectiveness of radiation therapy. Combining hyperbaric oxygen with radiation therapy may be an effective treatment for glioblastoma multiforme. PURPOSE: Phase I/II trial to study the effectiveness of combining radiation therapy with hyperbaric oxygen in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed description

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.

Interventions

DRUGhyperbaric oxygen

RADIATIONradiation therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026