Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva

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Brief Title

Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva

Official Title

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Uterine Cervix and/or Vulva

Brief Summary

      Current therapies for Stage IV Cancer of the Cervix and/or Vulva 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 IV Cancer of the Cervix and/or Vulva.

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

Detailed Description

      Stage IV Cancer of the Cervix and/or Vulva patients receive gradually escalating doses of
      intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose
      is reached. Treatment continues up to12 months in the absence of disease progression or
      unacceptable toxicity.

      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in patients with Stage IV Cancer of
           the Cervix and/or Vulva, 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
           IV Cancer of the Cervix and/or Vulva.

        -  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 Phase

Phase 2

Study Type

Interventional




Condition

Cervical Cancer Stage IV

Intervention

Antineoplaston therapy (Atengenal + Astugenal)

Study Arms / Comparison Groups

 Antineoplaston therapy
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

8

Start Date

June 3, 1996

Completion Date

January 22, 1998

Primary Completion Date

January 22, 1998

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically proven incurable stage IV carcinoma of the uterine cervix and/or vulva
             that is unlikely to respond to existing therapy

          -  Measurable disease by MRI or CT scan

          -  Tumor must be at least 2 cm

        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:

          -  No hepatic insufficiency

          -  Bilirubin no greater than 2.5 mg/dL

          -  SGOT and SGPT no greater than 5 times upper limit of normal

        Renal:

          -  No renal insufficiency

          -  Creatinine no greater than 2.5 mg/dL

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

        Cardiovascular:

          -  No known chronic heart failure

          -  No uncontrolled hypertension

          -  No history of congestive heart failure

          -  No history of other cardiovascular conditions that contraindicate high dosages of
             sodium

        Pulmonary:

          -  No serious lung disease, such as chronic obstructive pulmonary disease

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Not a high medical or psychiatric risk

          -  No concurrent nonmalignant systemic disease

          -  No active infection

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since prior immunotherapy and recovered

          -  No concurrent immunomodulatory agents

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

        Endocrine therapy:

          -  At least 1 month since prior tamoxifen if no progression

               -  May enter study immediately if evidence of progression

          -  Concurrent corticosteroids allowed

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy and recovered

        Surgery:

          -  Recovered from prior surgery

        Other:

          -  Prior cytodifferentiating agents allowed

          -  No prior antineoplastons

          -  No other concurrent antineoplastic agents
      

Gender

Female

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Stanislaw R. Burzynski, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00003525

Organization ID

CDR0000066569

Secondary IDs

BC-UC-02

Responsible Party

Sponsor

Study Sponsor

Burzynski Research Institute


Study Sponsor

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


Verification Date

September 2017