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

Alternate Title

Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	BC-BT-16 NCT00003471

Objectives

1. Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with low-grade astrocytoma.
2. Describe response to, tolerance to, and side effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed low-grade astrocytoma that has progressed, recurred, or persisted after initial therapy, including radiotherapy



• Previously treated with at least 1 prior standard therapy (e.g., radiotherapy, chemotherapy, immunotherapy, or cytodifferentiating agent)
  • Must have failed standard therapy



• Measurable disease by MRI or CT scan
  • Tumor must be at least 5 mm



• No brain stem tumors

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• At least 4 weeks since prior immunotherapy and recovered
• No concurrent immunomodulating agents

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• See Disease Characteristics
• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Must recover from prior surgery

Other:

• No prior antineoplastons

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 2 months

Hematopoietic:

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

Hepatic:

• Bilirubin no greater than 2.5 mg/dL
• SGOT and SGPT no greater than 5 times upper limit of normal
• No hepatic failure

Renal:

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

Cardiovascular:

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

Pulmonary:

• No severe lung disease (e.g., chronic obstructive pulmonary disease)

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No other concurrent serious disease
• No active infection

Expected Enrollment

A total of 20-40 patients will be accrued for this study.

Outline

This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 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 Low Grade Astrocytoma
Trial Start Date		1998-08-04
Registered in ClinicalTrials.gov		NCT00003471
Date Submitted to PDQ		1998-08-04
Information Last Verified		2004-04-08

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