RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have stage IV lung cancer.

OBJECTIVES:

• Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable adenocarcinoma of the lung.
• Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

• Drug: antineoplaston A10
• Drug: antineoplaston AS2-1

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