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

Alternate Title

Antineoplaston Therapy in Treating Children With Visual Pathway Glioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	6 months to 17 years	Other	BC-BT-23 NCT00003477

Objectives

1. Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with visual pathway glioma by determining the proportion of patients who experience an objective tumor response.
2. Evaluate the adverse effects of and tolerance to this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed (unless medically contraindicated) visual pathway glioma that is unlikely to respond to existing therapy and for which no curative therapy exists
  • Evidence of tumor by MRI or CT scan



• Tumor must be at least 5 mm



• No brain stem tumors

Prior/Concurrent Therapy:

Biologic therapy:

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

Chemotherapy:

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

Endocrine therapy:

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

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Other:

• No prior antineoplaston therapy

Patient Characteristics:

Age:

• 6 months to 17 years

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2000/mm3
• Platelet count greater than 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 renal insufficiency
• 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 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
• No serious active infections or fever
• No other serious concurrent disease

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

This is an open label study.

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 12 months in the absence of disease progression and unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 8 weeks during the first 2 years, every 3 months during the third and fourth years, every 6 months during the fifth and sixth years, and yearly 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 Infusions in Children With Visual Pathway Glioma
Trial Start Date		1996-06-27
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00003477
Date Submitted to PDQ		1998-07-29
Information Last Verified		2009-06-07

Back to Top