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
OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with
newly diagnosed Glioblastoma Multiforme receive gradually escalating doses of intravenous
Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
Treatment continues for at least 12 months in the absence of disease progression or
- To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with
newly diagnosed Glioblastoma Multiforme, as measured by an objective response to therapy
(complete response, partial response or stable disease).
- To determine the safety and tolerance of Antineoplaston therapy in adults (≥ 18 years of
age) with newly diagnosed Glioblastoma Multiforme.
- To determine objective response, tumor size is measured utilizing MRI scans, which are
performed every 8 weeks for the first two years, every 3 months for the third and fourth
years, every 6 months for the 5th and sixth years, and annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
- 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
- 18 and over
- Karnofsky 60-100%
- More than 4 months
- WBC at least 1,500/mm^3
- Platelet count at least 50,000/mm^3
- Hemoglobin at least 10 g/dL
- No hepatic failure
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that would contraindicate high dosages of sodium
- No uncontrolled hypertension
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- No prior immunotherapy
- No concurrent immunomodulatory agents
- No prior chemotherapy
- No concurrent antineoplastic agents
- Concurrent corticosteroids for cerebral edema allowed
- No prior radiotherapy
- See Disease Characteristics
- Recovered from any prior surgery