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 recurrent or stage IV lung cancer.
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with recurrent or stage IV squamous cell lung cancer.
- 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 3 months in the absence of toxicity and disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Tumors are measured every 2 months during the first year and then every 3 months for the
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued into this study.
- Histologically confirmed recurrent or stage IV squamous cell lung cancer unlikely to
have a curative response to existing standard regimens
- Measurable disease by MRI or CT scan
- At least 2 cm in diameter
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2,000/mm3
- Platelet count at least 50,000/mm3
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
- Creatinine no greater than 2.5 mg/dL
- No renal insufficiency
- No history of renal conditions that contraindicate high dosages of sodium
- No severe heart disease
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of
- No severe lung disease (e.g., chronic obstructive pulmonary disease)
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No serious active infections
- No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulating agents
- At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered
- No concurrent antineoplastic agents
- Concurrent corticosteroids allowed
- At least 8 weeks since prior radiotherapy and recovered
- Recovered from prior surgery
- No prior antineoplaston therapy
- Prior cytodifferentiating agent allowed