Antineoplaston Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Treatments||antineoplaston a10, antineoplaston as2-1|
|Sponsor||Burzynski Research Institute|
|Start date||August 1998|
|Trial size||40 participants|
|Trial identifier||NCT00003497, BC-LA-10, CDR0000066536|
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 capsules in treating patients who have stage IV non-small cell lung cancer.
Male or female participants at least 18 years old.
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
|Official title||Phase II Study of Antineoplastons A10 and AS2-1 Capsules In Patients With Non Small Cell Lung Cancer|
|Description||OBJECTIVES: - Demonstrate the antitumor activity of antineoplaston A10 and AS2-1 capsules in patients with non-small cell lung cancer by determining the proportion of patients who experience an objective tumor response. - Evaluate the adverse effects of and tolerance to this regimen in these patients. OUTLINE: This is an open-label study. Patients 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. Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.|
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