NCT00003456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 1995

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

March 14, 1995

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2004

Completed
13 years until next milestone

Results Posted

Study results publicly available

December 13, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

9.7 years

First QC Date

November 1, 1999

Results QC Date

July 24, 2017

Last Update Submit

March 7, 2018

Conditions

Glioblastoma Multiforme of Brain

Keywords

adult glioblastoma

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, 36 months, 48 months, 60 months

Study Arms (1)

Antineoplaston therapy

EXPERIMENTAL

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.

Drug: Antineoplaston therapy (Atengenal + Astugenal)

Interventions

Antineoplaston therapy (Atengenal + Astugenal)DRUG

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.

Also known as: A10 (Atengenal); AS2-1 (Astugenal)
Antineoplaston therapy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

Related Links

MeSH Terms

Conditions

Glioblastoma

Interventions

antineoplaston A10antineoplaston AS 2-1

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Results Point of Contact

Title
S. R. Burzynski, MD, PhD
Organization
Burzynski Research Institute, Inc.
srb@burzynskiclinic.com
713-335-5664

Study Officials

  • Stanislaw R. Burzynski, MD, PhD

    Burzynski Research Institute

    PRINCIPAL INVESTIGATOR

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

March 14, 1995

Primary Completion

December 7, 2004

Study Completion

December 7, 2004

Last Updated

March 22, 2018

Results First Posted

December 13, 2017

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)