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Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma

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ClinicalTrials.gov Identifier: NCT00003535
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Results First Posted : December 13, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute

Brief Summary:

RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with recurrent/progressive high grade gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) with recurrent/progressive high grade gliomas.


Condition or disease Intervention/treatment Phase
High Grade Glioma Drug: Antineoplaston therapy (Atengenal + Astugenal) Phase 2

Detailed Description:

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in children with recurrent/progressive high grade gliomas, 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 children with recurrent/progressive high grade gliomas.

OVERVIEW: This is a single arm, open-label study in which children with recurrent/progressive high grade gliomas 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 for this study.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 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 Children With High Grade Glioma
Study Start Date : April 1994
Actual Primary Completion Date : January 1998
Actual Study Completion Date : January 1998


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)
Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Other Name: A10 (Atengenal); AS2-1 (Astugenal)



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.


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



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma) that is recurrent or progressive or with residual tumor after standard therapy, including radiotherapy
  • Measurable tumor by MRI scan performed within two weeks prior to study entry
  • Male or female patients
  • Children 6 months to 17 years
  • Performance status: Karnofsky 60-100%
  • Life expectancy of at least 2 months
  • WBC greater than 1,500/mm^3
  • Platelet count greater than 50,000/mm^3
  • No evidence of hepatic or renal insufficiency and a total bilirubin and serum creatinine no greater than 2.5 mg/dL and SGOT/SGPT no greater than 5 times upper limit of normal
  • Must have recovered from adverse effect of previous therapy
  • At least 8 weeks elapsed since last dose of radiation
  • At least 4 weeks elapsed since last dose of chemotherapy (6 weeks for nitrosoureas)
  • Corticosteroids permitted using the smallest dose that is compatible with preservation of optimal neurologic function
  • Acceptable methods of birth control (in females of child-bearing potential or in sexually active males)during and up to four weeks following completion of study

Exclusion Criteria:

  • Prior A10 and AS2-1 treatment
  • Severe heart disease
  • Uncontrolled hypertension
  • Lung disease
  • Hepatic failure
  • Serious active infections, fever or other serious concurrent disease that would interfere with the evaluation of the treatment drug.
  • Pregnant or nursing
  • Serious concurrent disease
  • Concurrent antineoplastic or immunomodulatory agents

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): NCT00003535


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

Additional Information:
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003535     History of Changes
Other Study ID Numbers: CDR0000066582
BC-BT-06 ( Other Identifier: Burzynski Research Institute, Inc. )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Burzynski Research Institute:
childhood anaplastic astrocytoma
childhood glioblastoma multiforme

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue