Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Wolfgang Sauerwein

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00004015
Information obtained from ClinicalTrials.gov on December 22, 2011

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