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Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Ovarian Cancer

Sponsor
Burzynski Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT00003532
Collaborator
(none)
7
Enrollment
1
Location
1
Arm
79.4
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Current therapies for Stage III or IV Ovarian 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 Stage III or IV Ovarian Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage III or IV Ovarian Cancer.

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

Detailed Description

Stage III or IV Ovarian 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 Stage III or IV Ovarian 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 Stage III or IV Ovarian 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 :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Carcinoma of the Ovary
Actual Study Start Date :
Mar 5, 1996
Actual Primary Completion Date :
Oct 18, 2002
Actual Study Completion Date :
Oct 18, 2002

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 Stage III or IV Ovarian 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:
      18 Years to 99 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      DISEASE CHARACTERISTICS:

      • Histologically confirmed stage III or IV epithelial or germ cell ovarian cancer that is unlikely to respond to existing therapy and for which no curative therapy exists

      • Measurable disease by CT scan or MRI

      PATIENT CHARACTERISTICS:
      Age:
      • 18 and over
      Performance status:
      • Karnofsky 60-100%
      Life expectancy:
      • At least 2 months
      Hematopoietic:

      • WBC at least 2,000/mm^3

      • Platelet count at least 50,000/mm^3

      Hepatic:

      • Bilirubin no greater than 2.5 mg/dL

      • SGOT/SGPT no greater than 5 times upper limit of normal

      • No hepatic failure

      Renal:

      • Creatinine no greater than 2.5 mg/mL

      • No renal insufficiency

      • No history of renal conditions that contraindicate high dosages of sodium

      Cardiovascular:

      • No uncontrolled hypertension

      • No history of congestive heart failure

      • No other cardiovascular conditions that contraindicate high dosages 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, during, and for 4 weeks after study participation

      • No active infection

      • No concurrent serious systemic disease

      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
      Endocrine therapy:
      • Concurrent corticosteroids allowed (e.g., dexamethasone or methylprednisone)
      Radiotherapy:
      • At least 8 weeks since prior radiotherapy and recovered
      Surgery:
      • Recovered from prior surgery
      Other:

      • Prior cytodifferentiating agents allowed

      • No prior antineoplaston therapy

      • No other concurrent antineoplastic agents

      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:
      NCT00003532
      Other Study ID Numbers:
      • CDR0000066579
      • BC-OV-2
      First Posted:
      Jan 27, 2003
      Last Update Posted:
      Dec 12, 2017
      Last Verified:
      Dec 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
      Stage III ovarian epithelial cancer
      Stage IV ovarian epithelial cancer
      Stage III ovarian germ cell tumor
      Stage IV ovarian germ cell tumor
      Additional relevant MeSH terms:
      Ovarian Neoplasms
      Carcinoma, Ovarian Epithelial

      Study Results

      No Results Posted as of Dec 12, 2017