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Antineoplaston Therapy in Treating Patients With Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003457
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : December 16, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Current therapies for adults with persistent or recurrent brain tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with persistent or recurrent brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with persistent or recurrent brain tumors.


Condition or disease Intervention/treatment Phase
Refractory Brain Tumors Drug: Antineoplaston therapy (Atengenal + Astugenal) Phase 2

Detailed Description:

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in adults with persistent or recurrent brain tumors 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 persistent or recurrent brain tumors.

OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent brain tumors 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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 Brain Tumors.
Study Start Date : July 1996
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

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)
Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
Other Name: A10 (Atengenal); AS2-1 (Astugenal)


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Objective Response [ Time Frame: 12 months ]
    Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), < 50% decrease and < 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.


Secondary Outcome Measures :
  1. Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ]
    6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed brain tumor (except brain stem locations) that is unlikely to respond to existing therapy and for which no curative therapy exists
  • Evidence of persistent or recurrent brain tumor by MRI scan performed within two weeks prior to study entry
  • Tumor must be at least 5 mm
  • Ineligible for other Burzynski Research Institute, Inc. brain tumor protocols

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Hemoglobin at least 9 g/dL
  • 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 serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No concurrent antineoplastic agents

Endocrine therapy:

  • Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at least 1 week prior to study entry)

Radiotherapy:

  • At least 8 weeks since prior radiotherapy

Surgery:

  • Must recover from prior surgery

Other:

  • Prior cytodifferentiating agent allowed
  • No prior antineoplaston therapy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003457


Locations
United States, Texas
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
More Information

Additional Information:
Publications:
Burzynski SR, Janicki TJ, Burzynski GS. A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Primary Brain Tumors—Final Report (Protocol BT-09). Journal of Cancer Therapy 6(12): 1063-1074, 2015. DOI: 10.4236/jct.2015.612116

Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003457     History of Changes
Other Study ID Numbers: CDR0000066489
BC-BT-9 ( Other Identifier: Burzynski Research Institute, Inc. )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: December 16, 2016
Last Update Posted: August 22, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Burzynski Research Institute:
Anaplastic astrocytoma
Anaplastic astrocytoma/Mixed
Astrocytoma
Astrocytoma/Pilocytic
Brainstem glioma
Glioblastoma multiforme
Glioma
Neurocytoma
Primitive neuroectodermal tumor
Tectal glioma

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases