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 studies the effectiveness of antineoplaston therapy in treating patients who have stage III or stage IV prostate cancer.

Further Study Information

OBJECTIVES:

• 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.

• Evaluate the adverse effects of and tolerance to this regimen in these patients.

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.

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

Eligibility 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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3000/mm^3

• Platelet count at least 100,000/mm^3

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Burzynski Clinic

Stanislaw R. Burzynski

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003516
Information obtained from ClinicalTrials.gov on December 14, 2011

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