Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma

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Brief Title

Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma

Official Title

Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Anaplastic Astrocytoma

Brief Summary

      RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit
      to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may
      prove beneficial in the treatment of adults with anaplastic astrocytoma.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults with anaplastic astrocytoma.

Detailed Description


        -  To determine the efficacy of Antineoplaston therapy in adults with anaplastic
           astrocytoma 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 adults with
           anaplastic astrocytoma.

      OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma
      receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal +
      Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12
      months in the absence of disease progression or unacceptable toxicity. After 12 months,
      patients with a complete or partial response or with stable disease may continue treatment.

      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.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Study Phase

Phase 2

Study Type


Primary Outcome

Number of Participants With Objective Response

Secondary Outcome

 Percentage of Participants Who Survived


Adult Brain Tumor


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.


* 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


Estimated Enrollment


Start Date

April 1995

Completion Date

October 2008

Primary Completion Date

October 2008

Eligibility Criteria


          -  Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma

          -  Tumor subtotally resected or biopsied prior to therapy

          -  Evidence of residual tumor by MRI scan performed within two weeks prior to study entry

          -  No brain stem tumors



          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  More than 2 months


          -  WBC at least 1,500/mm^3

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

          -  Hemoglobin at least 10 g/dL


          -  Bilirubin no greater than 2.5 mg/dL

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

          -  No hepatic failure


          -  Creatinine no greater than 2.5 mg/dL

          -  No renal failure


          -  No prior congestive heart failure

          -  No coronary artery disease

          -  No myocardial infarction within the past year

          -  No angina requiring medication

          -  No uncontrolled hypertension


          -  No moderate to severe chronic obstructive pulmonary disease


          -  Not pregnant or nursing

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

          -  No active infection

          -  No other concurrent serious disease

          -  No other prior malignancy except carcinoma in situ of the cervix or superficial
             nonmelanoma skin cancer


        Biologic therapy:

          -  No prior immunotherapy

          -  No concurrent immunomodulating agents


          -  No prior myelosuppressive chemotherapy

        Endocrine therapy:

          -  Concurrent corticosteroids for cerebral edema allowed


          -  No prior myelosuppressive radiotherapy

          -  No concurrent radiotherapy


          -  See Disease Characteristics

          -  Recovered from any prior surgery


          -  No prior cytodifferentiating agents

          -  No prior antineoplaston therapy

          -  No other concurrent antineoplastic agents




18 Years - 99 Years

Accepts Healthy Volunteers



Stanislaw R. Burzynski, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

Burzynski Research Institute

Study Sponsor

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

Verification Date

July 2017