Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma Multiforme of Brain
• Intervention / Treatment: Drug: Antineoplaston therapy (Atengenal + Astugenal)

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77055-6330
      • Burzynski Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Antineoplaston therapy; 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); 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.; Other Names: A10 (Atengenal); AS2-1 (Astugenal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Survived	6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival	6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Collaborators and Investigators

• Sponsor: Burzynski Research Institute

Publications and helpful links

Helpful Links

• Burzynski Research Institute
• Burzynski Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 1995
• Primary Completion (Actual): December 7, 2004
• Study Completion (Actual): December 7, 2004

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: adult glioblastoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: CDR0000066488; BRI-BT-07 (Other Identifier: Burzynski Research Institute, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes