Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer

OVERVIEW: This is a single arm, open-label study in which patients with metastatic or
unresectable Colon Cancer cancer 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 metastatic or
unresectable Colon Cancer, 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
metastatic or unresectable Colon Cancer.

- 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 adenocarcinoma of the colon that is unlikely to respond to
existing therapy and for which no curative therapy exists

- Metastatic or unresectable disease

- Measurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

- 18 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:

- Bilirubin no greater than 2.5 mg/dL

- SGOT/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

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

Cardiovascular:

- No chronic heart failure

- 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 other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent immunomodulatory 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 (patients with multiple tumors
may be admitted earlier)

Surgery:

- Recovered from prior surgery

Other:

- Prior cytodifferentiating agent allowed

- No prior antineoplaston therapy