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Antineoplaston Therapy in Treating Patients With Primary Liver Cancer

Sponsor
Burzynski Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT00003530
Collaborator
(none)
3
Enrollment
1
Location
1
Arm
270.9
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Antineoplaston therapy (Atengenal + Astugenal)
 Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Antineoplaston A10 in Patients With Primary Liver Cancer
Actual Study Start Date :
Mar 21, 1977
Actual Primary Completion Date :
Oct 17, 1999
Actual Study Completion Date :
Oct 17, 1999

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antineoplaston Therapy

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)
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.
Other Names:
  • A10 (Atengenal); AS2-1 (Astugenal)

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      14 Years to 99 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Burzynski Clinic Houston Texas United States 77055-6330

      Sponsors and Collaborators

      • Burzynski Research Institute

      Investigators

      • Principal Investigator: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Burzynski Research Institute
      ClinicalTrials.gov Identifier:
      NCT00003530
      Other Study ID Numbers:
      • CDR0000066577
      • BC-HE-2
      First Posted:
      Jan 27, 2003
      Last Update Posted:
      Nov 21, 2017
      Last Verified:
      Nov 1, 2017
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Studies a U.S. FDA-regulated Drug Product:
      Yes
      Studies a U.S. FDA-regulated Device Product:
      No
      Keywords provided by Burzynski Research Institute
      Childhood primary liver cancer
      Adult primary liver cancer
      Additional relevant MeSH terms:
      Liver Neoplasms

      Study Results

      No Results Posted as of Nov 21, 2017