Antineoplaston Therapy in Treating Patients With Primary Liver Cancer
This trial is active, not recruiting.
|Sponsor||Burzynski Research Institute|
|Start date||August 1998|
|Trial size||40 participants|
|Trial identifier||NCT00003530, BC-HE-2, CDR0000066577|
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 primary liver cancer.
Male or female participants at least 14 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed primary liver cancer that is unlikely to respond to existing therapy and for which no curative therapy exists - Measurable disease by CT scan or MRI - Tumor must be at least 2 cm PATIENT CHARACTERISTICS: Age: - 14 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm3 - Platelet count at least 50,000/mm3 Hepatic: - Bilirubin less than 3 mg/dL - SGOT/SGPT no greater than 10 times upper limit of normal - No hepatic failure Renal: - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high doses of sodium Cardiovascular: - No uncontrolled hypertension - No known chronic heart failure - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high doses of sodium Pulmonary: - No serious lung disease (e.g., chronic obstructive pulmonary disease) Other: - Not pregnant or nursing - Fertile patients must use effective contraception for 4 weeks before study, during study, and for 4 weeks after study - No serious medical or psychiatric disease - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulating agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - Concurrent steroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Recovered from prior surgery Other: - No prior antineoplaston therapy - Prior cytodifferentiating agents allowed
|Official title||Phase II Study of Antineoplaston A10 in Patients With Primary Liver Cancer|
|Description||OBJECTIVES: - Determine the response, tolerance to, and side effects of antineoplaston A10 in patients with incurable primary liver cancer. OUTLINE: This is an open label study. Patients receive gradually increasing doses of antineoplaston A10 by arterial infusion daily until the final dose level is reached. Therapy continues for at least 2 months in the absence of unacceptable toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 2 months after reaching CR. Tumors are measured every month for the first 2 months, every 2 months for the first year, and every 3 months for the second year. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.|
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