Antineoplaston Therapy in Treating Patients With Primary Liver Cancer

Phase 2TerminatedNCT00003530

Burzynski Research Institute3 enrolled

Overview

Current therapies for Primary Liver Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Primary Liver Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Head and Neck Cancer.

Primary Liver Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with advanced Primary Liver Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with advanced Primary Liver Cancer. * To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Liver Cancer

Interventions

Antineoplaston therapy (Atengenal + Astugenal)DRUG

Patients with Primary Liver Cancer Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Burzynski Clinic

Houston, Texas, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.