Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in adults with recurrent or
refractory mixed gliomas 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 with recurrent
or refractory mixed gliomas.

OVERVIEW: This is a single arm, open-label study in which adults with recurrent or refractory
mixed gliomas 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 unacceptable toxicity. After 12
months, patients with a complete or partial response or with stable disease may continue
treatment.

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

DISEASE CHARACTERISTICS:

- Histologically confirmed incurable primary mixed glioma that is recurrent or
refractory following standard therapy, including radiation therapy

- Evidence of recurrent or refractory tumor by MRI scan performed within two weeks prior
to study entry

- Must have received and failed standard therapy

- Tumor must be at least 5 mm

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2000/mm3

- Platelet count at least 50,000/mm3

Hepatic:

- No hepatic insufficiency

- Bilirubin no greater than 2.5 mg/mL

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

Renal:

- No renal insufficiency

- Creatinine no greater than 2.5 mg/mL

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No known chronic heart failure

- No uncontrolled hypertension

- No history of congestive heart failure

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No severe lung disease

- No severe chronic obstructive pulmonary disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study

- No other severe medical illness

- No nonmalignant systemic disease

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since immunotherapy

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy (unless there is evidence of disease
progression)

Surgery:

- Fully recovered from prior surgery

Other:

- Prior cytodifferentiating agent allowed

- No prior antineoplaston therapy