This trial is active, not recruiting.

Condition liver cancer
Treatment antineoplaston a10
Phase phase 2
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).