Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma

Learn more about:
Related Clinical Trial
Induction of Cortical Plasticity S0114 Vaccine Therapy in Treating Patients With Gastric, Prostate, or Ovarian Cancer Laser Interstitial Thermal Therapy (LITT) for the Treatment of Pediatric Central Nervous System Tumors Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM Comparing Immobilisation Shells in Cranial Radiotherapy FBY PET/CT in Patients With Brain Tumors Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors Magnetic Resonance Spectroscopy Imaging in Predicting Response to Vorinostat and Temozolomide in Patients With Recurrent or Progressive Glioblastoma Longitudinal Metabolomic and Epigenetic Profiling of Bodyfluids From Patients With Lung and Brain Cancer Receiving Radiation Therapy Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients Prevalence of Post-craniotomy Headache in Siriraj Hospital Comparison of 6-fluoro-[18F]-L-dihydroxyphenylalanine (18F-DOPA) Positron Emission Tomography (PET) and Multiparametric Resonance Magnetic Imagery (RMI) in Initial Exploration of Glial Tumors Magnetic Resonance Imaging in Evaluating Response to RadiationTherapy in Patients With High Grade Glioma Wise Cortical Strip for Intraoperative Neurophysiological Monitoring Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma Translational Study of Nivolumab in Combination With Bevacizumab for Recurrent Glioblastoma Novel Gamma-Delta (γδ)T Cell Therapy for Treatment of Patients With Newly Diagnosed Glioblastoma Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI) A Study of Cognitive Changes in Patients Receiving Brain Radiation

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

      OBJECTIVES:

        -  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

Interventional


Primary Outcome

Number of Participants With Objective Response

Secondary Outcome

 Percentage of Participants Who Survived

Condition

Adult Brain Tumor

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

19

Start Date

April 1995

Completion Date

October 2008

Primary Completion Date

October 2008

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  More than 2 months

        Hematopoietic:

          -  WBC at least 1,500/mm^3

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

          -  Hemoglobin at least 10 g/dL

        Hepatic:

          -  Bilirubin no greater than 2.5 mg/dL

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

          -  No hepatic failure

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

          -  No renal failure

        Cardiovascular:

          -  No prior congestive heart failure

          -  No coronary artery disease

          -  No myocardial infarction within the past year

          -  No angina requiring medication

          -  No uncontrolled hypertension

        Pulmonary:

          -  No moderate to severe chronic obstructive pulmonary disease

        Other:

          -  Not pregnant or nursing

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

          -  No active infection

          -  No other concurrent serious disease

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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy

          -  No concurrent immunomodulating agents

        Chemotherapy:

          -  No prior myelosuppressive chemotherapy

        Endocrine therapy:

          -  Concurrent corticosteroids for cerebral edema allowed

        Radiotherapy:

          -  No prior myelosuppressive radiotherapy

          -  No concurrent radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  Recovered from any prior surgery

        Other:

          -  No prior cytodifferentiating agents

          -  No prior antineoplaston therapy

          -  No other concurrent antineoplastic agents
      

Gender

All

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

NCT00003537

Organization ID

CDR0000066585

Secondary IDs

BC-BT-8

Responsible Party

Sponsor

Study Sponsor

Burzynski Research Institute


Study Sponsor

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


Verification Date

July 2017