Study Stopped
Slow accrual
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
2 other identifiers
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 1994
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1994
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedResults Posted
Study results publicly available
December 13, 2017
CompletedMarch 21, 2018
March 1, 2018
3.8 years
November 1, 1999
August 1, 2017
March 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Objective Response
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.
12 months
Secondary Outcomes (1)
Percentage of Participants Who Survived
6 months, 12 months, 24 months
Study Arms (1)
Antineoplaston therapy
EXPERIMENTALAntineoplaston 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.
Interventions
Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Burzynski Clinic
Houston, Texas, 77055-6330, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- S. R. Burzynski, MD, PhD
- Organization
- Burzynski Research Institute, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
April 1, 1994
Primary Completion
January 1, 1998
Study Completion
January 1, 1998
Last Updated
March 21, 2018
Results First Posted
December 13, 2017
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share