Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	BRI-BT-20 NCT00003474

Objectives

1. Study the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable glioblastoma multiforme.
2. Describe response, tolerance to, and side effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy)
  • Measurable disease by MRI or CT scan



• Brain stem tumor is excluded



• Tumor must be at least 5 mm

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

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

Expected Enrollment

Approximately 20-40 patients will be accrued in this study.

Outline

Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 six times a day until the maximum tolerated dose is reached. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression.

Tumors are measured every 2 months during the first year and every 3 months during the second year.

Trial Contact Information

Trial Lead Organizations

Burzynski Clinic

Stanislaw Burzynski, MD, PhD, Protocol chair		Ph: 713-335-5697

Registry Information
Official Title		Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme
Trial Start Date		1998-08-04
Registered in ClinicalTrials.gov		NCT00003474
Date Submitted to PDQ		1998-08-04
Information Last Verified		2004-02-17

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