Expired Study
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Houston, Texas 77055


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00003530


Primary Contact:

Study Chair
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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