Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma
Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma
RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit
 to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may
 prove beneficial in the treatment of adults with anaplastic astrocytoma.

 PURPOSE: This study is being performed to determine the effects (good and bad) that
 Antineoplaston therapy has on adults with anaplastic astrocytoma.
OBJECTIVES:

 -  To determine the efficacy of Antineoplaston therapy in adults with anaplastic
 astrocytoma 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
 anaplastic astrocytoma.

 OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma
 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 or cytologically confirmed diagnosis of anaplastic astrocytoma

 -  Tumor subtotally resected or biopsied prior to therapy

 -  Evidence of residual tumor by MRI scan performed within two weeks prior to study entry

 -  No brain stem tumors

 PATIENT CHARACTERISTICS:

 Age:

 -  18 and over

 Performance status:

 -  Karnofsky 60-100%

 Life expectancy:

 -  More than 2 months

 Hematopoietic:

 -  WBC at least 1,500/mm^3

 -  Platelet count at least 50,000/mm^3

 -  Hemoglobin at least 10 g/dL

 Hepatic:

 -  Bilirubin no greater than 2.5 mg/dL

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

 -  No hepatic failure

 Renal:

 -  Creatinine no greater than 2.5 mg/dL

 -  No renal failure

 Cardiovascular:

 -  No prior congestive heart failure

 -  No coronary artery disease

 -  No myocardial infarction within the past year

 -  No angina requiring medication

 -  No uncontrolled hypertension

 Pulmonary:

 -  No moderate to severe chronic obstructive pulmonary disease

 Other:

 -  Not pregnant or nursing

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

 -  No active infection

 -  No other concurrent serious disease

 -  No other prior malignancy except carcinoma in situ of the cervix or superficial
 nonmelanoma skin cancer

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  No prior immunotherapy

 -  No concurrent immunomodulating agents

 Chemotherapy:

 -  No prior myelosuppressive chemotherapy

 Endocrine therapy:

 -  Concurrent corticosteroids for cerebral edema allowed

 Radiotherapy:

 -  No prior myelosuppressive radiotherapy

 -  No concurrent radiotherapy

 Surgery:

 -  See Disease Characteristics

 -  Recovered from any prior surgery

 Other:

 -  No prior cytodifferentiating agents

 -  No prior antineoplaston therapy

 -  No other concurrent antineoplastic agents