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

Alternate Title

Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	BC-PR-5 NCT00003516

Objectives

1. Determine the antitumor activity of antineoplaston A10 and AS2-1 capsules in patients with stage III or IV adenocarcinoma of the prostate by determining the proportion of patients who experience an objective response.
2. Evaluate the adverse effects of and tolerance to this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven stage III or IV adenocarcinoma of the prostate not potentially curable by surgery or radiotherapy



• Measurable tumors or tumor markers



• No response to antiandrogen withdrawal

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:

• At least 4 weeks since prior hormonal therapy and recovered
• Prior corticosteroids for at least 2 months allowed, but must be on stable or decreasing dose during study participation

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics
• At least 4 weeks since prior surgery and recovered

Other:

• At least 4 weeks since prior experimental clinical trial
• No other concurrent therapy for metastatic disease

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3000/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 2.5 mg/dL
• SGOT no greater than 2 times normal
• No hepatic failure

Renal:

• BUN less than 60 mg/dL
• Creatinine no greater than 2.5 mg/dL

  OR

• Creatinine clearance greater than 60 mL/min
• Blood ammonia normal
• No chronic renal failure

Cardiovascular:

• No severe heart disease

Pulmonary:

• No severe lung disease

Other:

• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No serious active infection or fever
• No other concurrent serious disease
• No other prior or concurrent malignancy within the past 2 years

Expected Enrollment

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

Outline

This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 capsules 6 to 7 times a day until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity.

Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually 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 Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate
Trial Start Date		1998-08-06
Registered in ClinicalTrials.gov		NCT00003516
Date Submitted to PDQ		1998-08-06
Information Last Verified		2004-04-08

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