Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV lung cancer
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 Stage IV lung
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 Stage
IV lung 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 stage IV adenocarcinoma of the lung that is unlikely to
respond to existing therapy and for which no curative therapy exists

- Measurable disease by MRI or CT scan

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:

- No hepatic insufficiency

- Bilirubin no greater than 2.5 mg/dL

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

Renal:

- Creatinine no greater than 2.5 mg/dL

- No renal insufficiency

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

Cardiovascular:

- No chronic heart disease that would preclude study treatment

- No history of chronic heart failure

- No uncontrolled hypertension

- No history of congestive heart failure

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

Pulmonary:

- No lung disease that would preclude study treatment

- No serious lung disease (e.g., severe chronic obstructive pulmonary disease)

Neurologic:

- No neurological disease that would preclude study treatment

Other:

- Not pregnant or nursing

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

- No gastrointestinal or psychiatric disease that would preclude study treatment

- No active infection

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

Surgery:

- Not specified

Other:

- Prior cytodifferentiating agents allowed

- No prior antineoplaston therapy