Antineoplaston Therapy in Treating Patients With Primary Liver Cancer

Primary Liver Cancer Clinical Trial

Official title:

Phase II Study of Antineoplaston A10 in Patients With Primary Liver Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003530
• Other study ID #: CDR0000066577
• Secondary ID: BC-HE-2
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: November 19, 2017
• Start date: March 21, 1977
• Est. completion date: October 17, 1999

Study information

• Verified date: November 2017
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 17, 1999
• Est. primary completion date: October 17, 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Primary Liver Cancer

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
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.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

External Links

•   Burzynski Clinic
•   Burzynski Research Institute