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 Rhabdoid Tumor of the Central Nervous System

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	6 months to 17 years	Other	BC-BT-14 NCT00003469

Objectives

1. Demonstrate the antitumor activity of antineoplastons A10 and AS2-1 in children with rhabdoid tumor of the central nervous system 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 rhabdoid tumor of the central nervous system 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

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 (6 weeks for nitrosoureas) and recovered
• No concurrent antineoplastic agents

Endocrine therapy:

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

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Other:

• No prior antineoplaston treatment

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 and 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 uncontrolled hypertension
• No severe heart disease
• 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 concomitant disease

Expected Enrollment

A total of 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 antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. After 2 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, 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 Children With Rhabdoid Tumor of the Central Nervous System
Trial Start Date		1996-02-29
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00003469
Date Submitted to PDQ		1998-07-29
Information Last Verified		2008-12-21