Purpose:
Current therapies for Soft Tissue Sarcoma provide very limited benefit to the patient. The
anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the
treatment of Soft Tissue Sarcoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Soft Tissue Sarcoma.
Study summary:
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.
Criteria:
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