search
Back to results

Antineoplaston Therapy in Treating Children With Brain Tumors

Primary Purpose

Childhood Brain Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antineoplaston therapy (Atengenal + Astugenal)
Sponsored by
Burzynski Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Brain Tumors focused on measuring Anaplastic astrocytoma, Anaplastic glioma, Anaplastic oligodendroglioma, Astrocytoma, Astrocytoma pilocytic, Brain stem glioma, Craniopharyngioma, Ganglioglioma, Glioblastoma multiforme, Gliosarcoma, Medulloepithelioma, Neurocytoma, Oligodendroglioma, Oligodendroglioma-brainstem, Primitive neuroectodermal tumor

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed (except if medically contraindicated) childhood brain tumor for which no curative therapy exists Measurable tumor by MRI scan performed within two weeks prior to study entry Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: 6 months to 17 years Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC greater than 2000/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT and 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 history of heart failure No history of other cardiovascular conditions that contraindicate high dosages of sodium No uncontrolled hypertension 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) and recovered No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week before study entry) Radiation therapy: At least 8 weeks since prior radiotherapy and recovered Surgery: Recovered from any prior surgery 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.

Secondary Outcome Measures

Percentage of Participants Who Survived
6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

Full Information

First Posted
November 1, 1999
Last Updated
March 3, 2022
Sponsor
Burzynski Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00003458
Brief Title
Antineoplaston Therapy in Treating Children With Brain Tumors
Official Title
Phase II Study of Antineoplastons A10 and AS2-1 in Children With Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (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 childhood brain tumors provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) with brain tumors.
Detailed Description
OVERVIEW: This is a single arm, open-label study in which children with 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. OBJECTIVES: To determine the efficacy of Antineoplaston therapy in children with a brain tumor, 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 a brain tumor. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Brain Tumors
Keywords
Anaplastic astrocytoma, Anaplastic glioma, Anaplastic oligodendroglioma, Astrocytoma, Astrocytoma pilocytic, Brain stem glioma, Craniopharyngioma, Ganglioglioma, Glioblastoma multiforme, Gliosarcoma, Medulloepithelioma, Neurocytoma, Oligodendroglioma, Oligodendroglioma-brainstem, Primitive neuroectodermal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (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 brain tumor 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.
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
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed (except if medically contraindicated) childhood brain tumor for which no curative therapy exists Measurable tumor by MRI scan performed within two weeks prior to study entry Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: 6 months to 17 years Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC greater than 2000/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT and 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 history of heart failure No history of other cardiovascular conditions that contraindicate high dosages of sodium No uncontrolled hypertension 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) and recovered No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week before study entry) Radiation therapy: At least 8 weeks since prior radiotherapy and recovered Surgery: Recovered from any prior surgery 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, Ania Marszalek. A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Brain Tumors. Final Report (Protocol BT-10). Journal of Cancer Therapy 8: 173-187, 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 Brain Tumors

We'll reach out to this number within 24 hrs