Antineoplaston Therapy in Treating Patients With Primary Liver Cancer

• Status: Terminated
• Trial end date: 1999-10-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Burzynski Research Institute

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