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

Alternate Title

Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	BC-PR-8 NCT00003534

Objectives

1. Provide treatment with intravenous antineoplastons A10 and AS2-1 for patients with incurable adenocarcinoma of the prostate who failed to respond to treatment with antineoplaston A10 and AS2-1 capsules.
2. Describe response to, tolerance to, and side effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed incurable stage IV adenocarcinoma of the prostate that failed to respond to treatment with antineoplaston A10 and AS2-1 capsules and for which no curative therapy exists
  • Evidence of tumor by MRI or CT scan



• No prostate-specific antigen (PSA) response to antiandrogen withdrawal



• If PSA changes used to indicate progressive disease, then PSA must increase more than 50% on two determinations at least 2 weeks apart

Prior/Concurrent Therapy:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

• At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

• See Disease Characteristics
• At least 4 weeks since prior hormonal therapy and recovered
• Concurrent corticosteroids allowed if dose is stable or decreasing

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agents allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• Hemoglobin at least 9 g/dL
• WBC at least 2000/mm³
• Platelet count at least 50,000/mm³

Hepatic:

• No hepatic insufficiency
• Bilirubin no greater than 2.5 mg/dL
• SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

• Creatinine no greater than 2.5 mg/dL
• No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No known chronic heart failure
• 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:

• Fertile patients must use effective contraception during and for 4 weeks after study participation
• Not a high medical or psychiatric risk
• No concurrent nonmalignant systemic disease that would preclude therapy
• No active infection

Expected Enrollment

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

Outline

This is an open-label study.

Patients receive gradually increasing 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 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.

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 Antineoplaston A10 and AS2-1 in Patients With Adenocarcinoma of the Prostate
Trial Start Date		1998-08-07
Registered in ClinicalTrials.gov		NCT00003534
Date Submitted to PDQ		1998-08-07
Information Last Verified		2004-04-08

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