Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme

Burzynski Research Institute

Status and phase: Completed; Phase 2

Conditions: Glioblastoma Multiforme of Brain

Treatments: Drug: Antineoplaston therapy (Atengenal + Astugenal)

Study type: Interventional

Funder types: Other

Identifiers

NCT00003456

CDR0000066488

BRI-BT-07 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Antineoplaston therapy

Experimental group

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.

Treatment:

Drug: Antineoplaston therapy (Atengenal + Astugenal)