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

Alternate Title

Antineoplaston Therapy in Treating Patients With Brain Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	BC-BT-9 NCT00003457

Objectives

1. Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening brain tumors.
2. Describe response to, tolerance to, and side effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed (except brain stem locations) brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists



• Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron emission tomography



• Tumor must be at least 5 mm



• Ineligible for other BRI brain tumor protocols

Prior/Concurrent Therapy:

Biologic therapy:

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

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at least 1 week prior to study entry)

Radiotherapy:

• At least 8 weeks since prior radiotherapy

Surgery:

• Must recover from prior surgery

Other:

• Prior cytodifferentiating agent allowed
• No prior antineoplaston therapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• Hemoglobin at least 9 g/dL
• WBC at least 2,000/mm³
• Platelet count at least 50,000/mm³

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

• No severe lung disease

Other:

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

Expected Enrollment

Not specified

Outcomes

Response rate based on tumor measurements at 12 weeks

Survival at 1, 2, and 5 years from the start of treatment

Outline

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 2 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. Patients achieving partial response or stable disease continue treatment until disease progression.

Tumors are measured every 1-3 months for 2 years, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Burzynski Clinic

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

U.S.A.
Texas
	Houston
	Burzynski Clinic
		Stanislaw Burzynski, MD, PhD	Ph:  713-335-5697
			Email: info@burzynskiclinic.com

Registry Information
Official Title		Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Tumors
Trial Start Date		1996-07-23
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00003457
Date Submitted to PDQ		1998-07-29
Information Last Verified		2009-06-07

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