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Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme

Primary Purpose

Glioblastoma Multiforme of Brain

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 Glioblastoma Multiforme of Brain focused on measuring adult glioblastoma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed Glioblastoma Multiforme Subtotal resection or biopsy only of tumor Measurable tumor by MRI scan performed within two weeks prior to study entry Tumor must be at least 5 mm No brain stem tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 4 months Hematopoietic: WBC at least 1,500/mm^3 Platelet count at least 50,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: No hepatic failure Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL No history of renal conditions that would contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension Other: Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent immunomodulatory agents Chemotherapy: No prior chemotherapy No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids for cerebral edema allowed Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Recovered from any prior surgery

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 7, 2018
Sponsor
Burzynski Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00003456
Brief Title
Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme
Official Title
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 14, 1995 (Actual)
Primary Completion Date
December 7, 2004 (Actual)
Study Completion Date
December 7, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Burzynski Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme.
Detailed Description
OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme 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 adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme, 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 adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme. 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
Glioblastoma Multiforme of Brain
Keywords
adult glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (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
Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
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
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed Glioblastoma Multiforme Subtotal resection or biopsy only of tumor Measurable tumor by MRI scan performed within two weeks prior to study entry Tumor must be at least 5 mm No brain stem tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 4 months Hematopoietic: WBC at least 1,500/mm^3 Platelet count at least 50,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: No hepatic failure Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL No history of renal conditions that would contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension Other: Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent immunomodulatory agents Chemotherapy: No prior chemotherapy No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids for cerebral edema allowed Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Recovered from any prior surgery
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
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 Patients With Newly-diagnosed Glioblastoma Multiforme

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