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 Residual or Recurrent Anaplastic Astrocytoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	BC-BT-8 NCT00003537

Objectives

1. Determine the objective response rate in patients with anaplastic astrocytoma treated with antineoplastons A10 and AS2-1 after subtotal resection.
2. Assess tolerance to and side effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed anaplastic astrocytoma
  • Tumor subtotally resected or biopsied



• Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography



• No brain stem tumors

Prior/Concurrent Therapy:

Biologic therapy:

• No prior immunotherapy
• No concurrent immunomodulating agents

Chemotherapy:

• No prior myelosuppressive chemotherapy

Endocrine therapy:

• Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

• No prior myelosuppressive radiotherapy
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• Recovered from any prior surgery

Other:

• No prior cytodifferentiating agents
• No prior antineoplaston therapy
• No other concurrent antineoplastic agents

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 2 months

Hematopoietic:

• WBC at least 1,500/mm³
• Platelet count at least 50,000/mm³
• Hemoglobin at least 10 g/dL

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 failure

Cardiovascular:

• No prior congestive heart failure
• No coronary artery disease
• No myocardial infarction within the past year
• No angina requiring medication
• No uncontrolled hypertension

Pulmonary:

• No moderate to 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 active infection
• No other concurrent serious disease
• No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer

Expected Enrollment

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

Outcomes

Response rate assessed by tumor measurements at 12 weeks

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

Outline

This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 IV 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 stable disease or partial response may continue treatment. Patients achieving complete response (CR) continue treatment for an additional 8 months after CR.

Tumors are measured at 1 month, every 1-2 months for 2 years, every 3 months for the third year, every 4 months for the fourth year, every 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 Anaplastic Astrocytoma
Trial Start Date		1995-04-13
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00003537
Date Submitted to PDQ		1998-07-29
Information Last Verified		2009-06-07

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