Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
RATIONALE: Current therapies for adults with anaplastic astrocytomas that have not responded
 to standard therapy provide very 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 astrocytomas that have not responded to standard therapy.

 PURPOSE: This study is being performed to determine the effects (good and bad) that
 Antineoplaston therapy has on adults with anaplastic astrocytomas that have not responded to
 standard therapy.
OBJECTIVES:

 -  To determine the efficacy of Antineoplaston therapy in patients with anaplastic
 astrocytomas that have not responded to standard therapy, 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 patients with a
 anaplastic astrocytoma

 OVERVIEW: This is a single arm, open-label study in which adults withanaplastic astrocytomas
 that have not responded to standard therapy 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 incurable adult anaplastic astrocytoma

 -  Evidence of progressive or recurrent tumor by MRI scan performed within 2 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/mm^3

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

 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 history of renal conditions that contraindicate high dosages of sodium

 Cardiovascular:

 -  No uncontrolled hypertension

 -  No history of congestive heart failure

 -  No history of other cardiovascular conditions that contraindicate high dosages of
 sodium

 Pulmonary:

 -  No serious lung disease such as severe chronic obstructive pulmonary disease

 Other:

 -  Not pregnant or nursing

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

 -  No active infection

 -  No other serious concurrent disease

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  At least 4 weeks since prior immunotherapy and recovered

 -  No concurrent immunomodulating agents

 Chemotherapy:

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

 -  No concurrent antineoplastic agents

 Endocrine therapy:

 -  Concurrent corticosteroids allowed

 Radiotherapy:

 -  At least 8 weeks since prior radiotherapy and recovered

 Surgery:

 -  Fully recovered from any prior surgery

 Other:

 -  Prior cytodifferentiating agent allowed

 -  No prior antineoplaston therapy