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 Ependymoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	6 months and over	Other	BC-BT-24 NCT00003479

Objectives

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

Entry Criteria

Disease Characteristics:

• Histologically confirmed ependymoma 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 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/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 failure
• 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
• No serious active infections or fever
• No other serious concurrent disease

Expected Enrollment

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

Outcomes

Antitumor activity
Adverse effects
Treatment tolerance

Outline

This is an open label study.

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

Tumors are measured at least 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

Registry Information
Official Title		Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Patients With Ependymoma
Trial Start Date		1998-08-04
Registered in ClinicalTrials.gov		NCT00003479
Date Submitted to PDQ		1998-07-29
Information Last Verified		2006-09-17

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