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Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility


Phase 1
50 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility


OBJECTIVES:

- Determine systemic and local toxicity of borocaptate sodium with boron neutron capture
therapy (BNCT) following craniotomy with gross total resection in patients with
glioblastoma multiforme.

- Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated
dose of this regimen in these patients.

- Determine the maximum tolerated radiation dose of BNCT in cranial localization to
healthy tissues in these patients under defined conditions.

OUTLINE: This is a dose escalation, multicenter study.

Within 6 weeks of surgery, patients receive borocaptate sodium followed 12-18 hours later by
neutron irradiation. Treatment repeats daily for 4 days.

Cohorts of 3-9 patients receive escalating doses of neutron irradiation. The maximum
tolerated dose is defined as the dose preceding that at which 3 or more patients experience
dose limiting toxicity.

Patients are followed weekly for 4 weeks, monthly for 2 months, every 6 weeks for 15 months
and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven glioblastoma multiforme for which conventional radiotherapy
would be of little or no benefit

- Gross total resection of tumor confirmed by postoperative MRI performed within 48
hours of surgery

- Evaluable preoperative and postoperative MRI films with and without contrast must be
available

- No prior brain malignancy

- No prior craniotomy except for glioblastoma

PATIENT CHARACTERISTICS:

Age:

- 50 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin, SGOT, SGPT, and alkaline phosphatase no greater than 2.5 times normal
unless caused by reversible reaction to antiseizure medication

Renal:

- Blood urea nitrogen and creatinine no greater than 2.5 times upper limit of normal

Cardiovascular:

- No severe heart disease (e.g., congestive heart failure, angina pectoris)

Pulmonary:

- No severe dyspnea at time of diagnosis

- No severe obstructive or restrictive lung disease

Other:

- No other concurrent malignant tumor

- No severe gastrointestinal disease or active peptic ulcer disease

- No uncontrolled endocrine disease

- No serious mental disease, organic brain disease (e.g., preexisting epilepsy or
serious aphasia), or legally incapacitated patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy for glioblastoma multiforme

- No concurrent biologic therapy

Chemotherapy:

- No prior chemotherapy for glioblastoma multiforme

- No concurrent chemotherapy

Endocrine therapy:

- No prior endocrine therapy for glioblastoma multiforme except corticosteroids

- No concurrent endocrine therapy

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy for glioblastoma multiforme

- No prior radiotherapy to head and neck

- No other concurrent radiotherapy

Surgery:

- See Disease Characteristics

- Prior stereotactic biopsy allowed for glioblastoma multiforme

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration

Safety Issue:

Yes

Principal Investigator

Wolfgang Sauerwein, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Universitaetsklinikum Essen

Authority:

United States: Federal Government

Study ID:

EORTC-11961

NCT ID:

NCT00004015

Start Date:

June 2002

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

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