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

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003535
First Posted: January 27, 2003
Last Update Posted: December 13, 2017
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.
Information provided by (Responsible Party):
Burzynski Research Institute
November 1, 1999
January 27, 2003
August 1, 2017
December 13, 2017
December 13, 2017
April 1994
January 1998   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00003535 on ClinicalTrials.gov Archive Site
Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months, 24 months ]
6 months, 12 months, 24 months overall survival
Not Provided
Not Provided
Not Provided
 
Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma
Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
High Grade Glioma
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)
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.
Intervention: Drug: Antineoplaston therapy (Atengenal + Astugenal)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
January 1998
January 1998   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003535
CDR0000066582
BC-BT-06 ( Other Identifier: Burzynski Research Institute, Inc. )
No
Not Provided
Plan to Share IPD: No
Burzynski Research Institute
Burzynski Research Institute
Not Provided
Principal Investigator: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
Burzynski Research Institute
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP