Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma

Soft Tissue Sarcoma patients receive gradually escalating doses of intravenous Antineoplaston
therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment
continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with Soft Tissue
Sarcoma, 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 Soft
Tissue Sarcoma.

- 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.

DISEASE CHARACTERISTICS:

- Histologically confirmed soft tissue sarcoma that is unlikely to respond to existing
therapy, including surgery, radiotherapy, and chemotherapy

- Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan

PATIENT CHARACTERISTICS:

Age:

- 6 months and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2,000/mm^3

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

Hepatic:

- No hepatic insufficiency

- Bilirubin no greater than 2.5 mg/dL

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

Renal:

- No renal insufficiency

- 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 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 nonmalignant systemic disease

- Not high medical or psychiatric risk

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since immunotherapy

- No concurrent immunomodulating agents

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

Surgery:

- Recovered from prior surgery

Other:

- Prior cytodifferentiating agents allowed

- No prior antineoplastons

- No other concurrent antineoplastic agents