Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer

Brief Title

Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer

Official Title

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Adrenal Gland

Brief Summary

      Current therapies for Stage IV adrenal gland 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 IV adrenal gland cancer

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on patients with Stage IV adrenal gland cancer.
    

Detailed Description

      OVERVIEW: This is a single arm, open-label study in which patients with Stage IV adrenal
      gland cancer 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 adrenal
           gland 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
           IV adrenal gland 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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Number of Participants With Objective Response

Secondary Outcome

 Percentage of Participants Who Survived

Condition

Stage IV Adrenocortical Carcinoma

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 Status

Drug

Estimated Enrollment

6

Start Date

August 21, 1996

Completion Date

July 5, 2011

Primary Completion Date

July 5, 2011

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage IV adrenal gland carcinoma that is unlikely to respond
             to existing therapy and for which no curative therapy exists

          -  Measurable disease by MRI or CT scan

          -  Tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in
             the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the
             largest diameter for other localizations

        PATIENT CHARACTERISTICS:

        Age:

          -  6 months 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/dL

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

        Cardiovascular:

          -  No severe heart disease

          -  No uncontrolled hypertension

          -  No history of congestive heart failure

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

        Pulmonary:

          -  No severe lung disease

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 4 weeks after study
             participation

          -  No serious active infections or fever

          -  No other concurrent serious 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

          -  No concurrent antineoplastic agents

        Endocrine therapy:

          -  Concurrent corticosteroids allowed

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy and recovered

        Surgery:

          -  Recovered from any prior operative procedure

        Other:

          -  No prior antineoplaston therapy

          -  Prior cytodifferentiating agent allowed
      

Gender

All

Ages

6 Months - 99 Years

Accepts Healthy Volunteers

No

Contacts

Stanislaw R. Burzynski, MD, PhD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00003453

Organization ID

CDR0000066485

Secondary IDs

BC-AD-02

Responsible Party

Sponsor

Study Sponsor

Burzynski Research Institute

Study Sponsor

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

Verification Date

April 2018