Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme

NCT ID: NCT00003474

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-03-14
• Study Completion Date: 2003-06-21

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 residual/recurrent/progressive Glioblastoma Multiforme.

Detailed Description

OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with residual/recurrent/progressed 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 residual/recurrent/progressive Glioblastoma Multiforme following initial therapy, including radiotherapy, 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 residual/recurrent/progressive 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.

Conditions

Glioblastoma Multiforme of the Brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Antineoplaston therapy (Atengenal + Astugenal)

Intervention Type: DRUG

Adults with a residual/recurrent/progressive 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.

Interventions

Antineoplaston therapy (Atengenal + Astugenal)

Adults with a residual/recurrent/progressive 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.

Intervention Type: DRUG

Other Intervention Names

A10 (Atengenal); AS2-1 (Astugenal)

Eligibility Criteria

Exclusion Criteria

• Tumor must be at least 5 mm

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/mm3
• Platelet count at least 50,000/mm3

Hepatic:

• No liver failure
• Bilirubin no greater than 2.5 mg/dL
• SGOT/SGPT no greater than 5 times upper limit

Renal:

• No history of renal conditions that contraindicate high dosages of sodium
• Creatinine no greater than 2.5 mg/dL

Cardiovascular:

• No uncontrolled hypertension
• No history of congestive heart failure
• No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No serious lung disease (e.g., severe COPD)

Other:

• Not pregnant or nursing
• Fertile patients must use adequate contraception during and for 4 weeks after study
• No active infection
• No other serious medical or psychiatric conditions

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since immunotherapy
• No concurrent immunomodulating agents

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since chemotherapy (unless radiologically proven progression)
• At least 6 weeks since nitrosoureas

Endocrine therapy:

• Corticosteroids allowed

Radiotherapy:

• See Disease Characteristics
• At least 8 weeks since radiotherapy (unless radiologically proven progression)

Surgery:

• Recovered from prior surgery

Other:

• No prior antineoplaston therapy
• Prior cytodifferentiating agent allowed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Burzynski Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanislaw R. Burzynski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Burzynski Research Institute

Locations

Burzynski Clinic

Houston, Texas, United States

Countries

United States

Related Links

http://www.burzynskiresearch.com

Burzynski Research Institute

http://www.burzynskiclinic.com

Burzynski Clinic

Other Identifiers

BRI-BT-20

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000066511

Identifier Type: -

Identifier Source: org_study_id