NCT00003530

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 1977

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 1977

Completed
22.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 1999

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

22.6 years

First QC Date

November 1, 1999

Last Update Submit

November 19, 2017

Conditions

Primary Liver Cancer

Keywords

Childhood primary liver cancerAdult primary liver cancer

Study Arms (1)

Antineoplaston Therapy

EXPERIMENTAL

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Drug: Antineoplaston therapy (Atengenal + Astugenal)

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.

Also known as: A10 (Atengenal); AS2-1 (Astugenal)
Antineoplaston Therapy

Eligibility Criteria

Age14 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

antineoplaston A10antineoplaston AS 2-1

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Stanislaw R. Burzynski, MD, PhD

    Burzynski Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 21, 1977

Primary Completion

October 17, 1999

Study Completion

October 17, 1999

Last Updated

November 21, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)