Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with anaplastic astrocytoma that has not responded to previous treatment.

Further Study Information

OBJECTIVES:

• Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable anaplastic astrocytoma who experienced disease progression or recurrence or have residual disease after standard therapy.

• Describe response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: 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 3 months in the absence of toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months during the first year, every 3 months for the second year, every 3-4 months during the third and fourth years, every 4-6 months during the fifth year, and yearly thereafter.

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed incurable anaplastic astrocytoma that has progressed, recurred, or persisted after completion of standard therapy (including radiation therapy)

• Measurable disease by MRI or CT scan

• Tumor must be at least 5 mm

• Must have received prior standard therapy (i.e., radiation therapy, chemotherapy, immunotherapy, or cytodifferentiating agent)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2000/mm^3

• Platelet count at least 50,000/mm^3

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 history of congestive heart failure

• No history of 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

• No active infection

• No other serious concurrent disease

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 allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Fully recovered from any prior surgery

Other:

• Prior cytodifferentiating agent allowed

• No prior antineoplaston therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Burzynski Clinic

Stanislaw R. Burzynski

Study Chair

U.S.A.
Texas
	Houston
	Burzynski Clinic
		Stanislaw R. Burzynski, MD, PhD	Ph: 713-335-5697
			Email: info@burzynskiclinic.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003470
Information obtained from ClinicalTrials.gov on December 14, 2011

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