Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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