Back to resultsAntineoplaston Therapy in Treating Children With Visual Pathway Glioma (VPG)
Primary Purpose
Visual Pathway Glioma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antineoplaston therapy (Atengenal + Astugenal)
Sponsored by
About this trial
This is an interventional treatment trial for Visual Pathway Glioma focused on measuring visual pathway glioma not amenable to standard therapy, visual pathway glioma not responding to standard therapy
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed (unless medically contraindicated) visual pathway glioma, which is not amenable to standard therapy or did not respond to standard therapy. Evidence of tumor by MRI scan performed within 2 weeks prior to the study entry Tumor must be at least 5 mm No brain stem tumors PATIENT CHARACTERISTICS: Age: 6 months to 17 years Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2000/mm3 Platelet count greater than 50,000/mm3 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 renal insufficiency 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 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 No serious active infections or fever No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy and recovered (6 weeks for nitrosoureas) No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: At least 8 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No prior antineoplaston therapy
Sites / Locations
- Burzynski Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antineoplaston therapy
Arm 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.
Outcomes
Primary Outcome Measures
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. Stable Disease (SD): <50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four weeks. Progressive Disease (PD): >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
Secondary Outcome Measures
Percentage of Participants Who Survived
6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
Full Information
NCT ID
NCT00003477
First Posted
November 1, 1999
Last Updated
July 24, 2017
Sponsor
Burzynski Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00003477
Brief Title
Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
Acronym
VPG
Official Title
Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Children With Visual Pathway Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Burzynski Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.
Detailed Description
OBJECTIVES:
To determine the efficacy of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, 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 visual pathway gliomas, which are not amenable to or have not responded to standard therapy.
OVERVIEW: This is a single arm, open-label study in which children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, 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: Approximately 20-40 patients will be accrued to this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Pathway Glioma
Keywords
visual pathway glioma not amenable to standard therapy, visual pathway glioma not responding to standard therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antineoplaston therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Antineoplaston therapy (Atengenal + Astugenal)
Other Intervention Name(s)
A10 (Atengenal); AS2-1 (Astugenal)
Intervention Description
Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).
Primary Outcome Measure Information:
Title
Number of Participants With Objective Response
Description
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 in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four weeks. Progressive Disease (PD): >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Survived
Description
6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
Time Frame
6 months, 12 months, 24 months, 36 months, 48 months, 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed (unless medically contraindicated) visual pathway glioma, which is not amenable to standard therapy or did not respond to standard therapy.
Evidence of tumor by MRI scan performed within 2 weeks prior to the study entry
Tumor must be at least 5 mm
No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
6 months to 17 years
Performance status:
Karnofsky 60-100%
Life expectancy:
At least 2 months
Hematopoietic:
WBC at least 2000/mm3
Platelet count greater than 50,000/mm3
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 renal insufficiency
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 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
No serious active infections or fever
No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 4 weeks since prior immunotherapy and recovered
No concurrent immunomodulating agents
Chemotherapy:
At least 4 weeks since prior chemotherapy and recovered (6 weeks for nitrosoureas)
No concurrent antineoplastic agents
Endocrine therapy:
Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study)
Radiotherapy:
At least 8 weeks since prior radiotherapy and recovered
Surgery:
Not specified
Other:
No prior antineoplaston therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislaw R. Burzynski, MD, PhD
Organizational Affiliation
Burzynski Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burzynski Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77055-6330
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski. Antineoplastons A10 and AS2-1 in the Treatment of Children with Optic Pathway Glioma: Final Report for BT-23. Cancer and Clinical Oncology 6(1): 25-35, 2017
Results Reference
background
Links:
URL
http://www.burzynskiresearch.com
Description
Burzynski Research Institute
URL
http://www.burzynskiclinic.com
Description
Burzynski Clinic
Learn more about this trial
Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
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