Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Stage IV non-small cell lung cancers receive Antineoplaston A10 and AS2-1 capsules orally six
to seven times a day. Treatment continues in the absence of disease progression or
unacceptable toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with Stage IV non-small
cell 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 non-small cell lung cancer.

- To determine objective response, tumor size is measured utilizing MRI scans, which are
performed every 4 months for 2 years, every 6 months for 2 years, and then annually for
2 years thereafter.

DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV non-small cell lung cancer that cannot be cured with
existing therapeutic regimens

- Measurable disease by CT scan or MRI

- Tumor must be at least 2 cm for the lymph nodes located in the head, neck,
axillary, inguinal or femoral areas and at least 0.5 cm for other areas

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 and SGPT no greater than 5 times upper limit of normal

Renal:

- No renal insufficiency

- Creatinine no greater than 2.5 mg/dL

Cardiovascular:

- No chronic heart failure

- No uncontrolled hypertension

Pulmonary:

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

Other:

- Not pregnant or nursing

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

- No other serious medical or psychiatric conditions

- No active infection

- No serious malabsorption syndromes

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

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

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy (less than 8 weeks if multiple tumors are
involved) and recovered

Surgery:

- No prior extensive stomach or intestinal surgery

- Recovered from any prior surgery

Other:

- Prior cytodifferentiating agents allowed

- No prior antineoplaston treatment

- No other concurrent treatment for metastatic lung cancer