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 Primary Malignant Brain Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	BC-BT-21 NCT00003475

Objectives

1. Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable primary malignant brain tumor that has progressed during or is recurrent or persistent after prior standard therapy, including radiotherapy and/or chemotherapy.
2. Describe the response to, tolerance to, and side effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed incurable primary malignant brain tumor that has progressed during or is recurrent after prior initial therapy, including radiotherapy
  • Failed prior standard therapy



• Measurable disease by MRI or CT scan



• No brain stem tumors

Prior/Concurrent Therapy:

Biologic therapy:

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

Chemotherapy:

• At least 4 weeks since prior chemotherapy, except in patients with disease progression during initial therapy
• At least 6 weeks since prior nitrosoureas, except in patients with disease progression during initial therapy
• No concurrent antineoplastic agents

Endocrine therapy:

• Corticosteroids allowed

Radiotherapy:

• See Disease Characteristics
• At least 8 weeks since prior radiotherapy, except in patients with disease progression during initial therapy

Surgery:

• At least 4 weeks since prior surgery, except in patients with disease progression during initial therapy

Other:

• Recovered from prior therapy
• Cytodifferentiating agents allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• Hematological function normal
• WBC at least 2000/mm³
• Platelet count at least 50,000/mm³

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

• No serious lung disease, such as severe chronic obstructive pulmonary disease

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No medical or psychiatric illness that would preclude study treatment
• No active infection

Expected Enrollment

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

Outcomes

Response rate based on tumor measurements taken at 12 weeks

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

Outline

Patients receive gradually escalating doses of intravenous antineoplastons A10 and AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Patients are followed at least every 2 months for 1 year, every 3 months for the second year, 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 Adult Patients With Primary Malignant Brain Tumors
Trial Start Date		1996-02-26
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00003475
Date Submitted to PDQ		1998-07-29
Information Last Verified		2008-12-21