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Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors

Primary Purpose

Childhood Brain Tumor

Status
Terminated
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 Tumor focused on measuring childhood anaplastic astrocytoma, recurrent childhood anaplastic astrocytoma, childhood glioblastoma multiforme, recurrent childhood glioblastoma multiforme, childhood brainstem glioma, recurrent childhood brainstem glioma, childhood primitive neuroectodermal tumor, recurrent childhood primitive neuroectodermal tumor

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed incurable primary malignant brain tumor that has progressed, recurred, or persisted after initial therapy (must have failed standard therapy). Evidence of residual tumor by MRI performed within two weeks prior to study entry PATIENT CHARACTERISTICS: Age: 6 months to 17 years Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 1,500/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: No hepatic failure Bilirubin no greater than 2.5 mg/dL SGOT/SGPT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No severe heart disease 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 and recovered No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic agents Endocrine therapy: Recovered from prior endocrine therapy Concurrent corticosteroids for cerebral edema allowed Radiotherapy: At least 8 weeks since prior radiotherapy (unless clear radiological evidence of progression) and recovered Surgery: At least 4 weeks since prior surgery (unless clear radiological evidence of progression) and recovered 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 and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight 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
Six months and Twelve months overall survival

Full Information

First Posted
November 1, 1999
Last Updated
July 24, 2017
Sponsor
Burzynski Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00003476
Brief Title
Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
Official Title
Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
March 1996 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (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 primary malignant 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 children with primary malignant brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with primary malignant brain tumors.
Detailed Description
OBJECTIVES: To determine the efficacy of Antineoplaston therapy in children with primary malignant brain tumors 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 primary malignant brain tumors. OVERVIEW: This is a single arm, open-label study in which children with primary malignant 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. 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 to this study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Brain Tumor
Keywords
childhood anaplastic astrocytoma, recurrent childhood anaplastic astrocytoma, childhood glioblastoma multiforme, recurrent childhood glioblastoma multiforme, childhood brainstem glioma, recurrent childhood brainstem glioma, childhood primitive neuroectodermal tumor, recurrent childhood 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
8 (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 primary malignant 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; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight 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
Six months and Twelve months overall survival
Time Frame
6 months, 12 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 incurable primary malignant brain tumor that has progressed, recurred, or persisted after initial therapy (must have failed standard therapy). Evidence of residual tumor by MRI performed within two weeks prior to study entry PATIENT CHARACTERISTICS: Age: 6 months to 17 years Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 1,500/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: No hepatic failure Bilirubin no greater than 2.5 mg/dL SGOT/SGPT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No severe heart disease 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 and recovered No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic agents Endocrine therapy: Recovered from prior endocrine therapy Concurrent corticosteroids for cerebral edema allowed Radiotherapy: At least 8 weeks since prior radiotherapy (unless clear radiological evidence of progression) and recovered Surgery: At least 4 weeks since prior surgery (unless clear radiological evidence of progression) and recovered 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
Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A, Brookman, S. A phase II study of Antineoplastons A10 and AS2-1 in children with recurrent, refractory or progressive primary brain tumors - Final Report (Protocol BT-22). Journal of Cancer Therapy, 5:977-988, 2014.
Results Reference
background
Links:
URL
http://www.burzynskiresearch.com
Description
Burzynski Research Institute
URL
http://www.burzynskiclinic.com
Description
Burzynski Clinic

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Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors

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