Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2004-12-07
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed Glioblastoma Multiforme

• Subtotal resection or biopsy only of tumor

• Measurable tumor by MRI scan performed within two weeks prior to study entry

• Tumor must be at least 5 mm

• No brain stem tumor

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 4 months

Hematopoietic:

• WBC at least 1,500/mm^3

• Platelet count at least 50,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• No hepatic failure

• Bilirubin no greater than 2.5 mg/dL

• SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

• Creatinine no greater than 2.5 mg/dL

• No history of renal conditions that would contraindicate high dosages of sodium

Cardiovascular:

• No uncontrolled hypertension

Other:

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy

• No concurrent immunomodulatory agents

Chemotherapy:

• No prior chemotherapy

• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics

• Recovered from any prior surgery