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

Study Overview
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Brief Summary
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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 stage III or stage IV prostate cancer.

Detailed Description
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OBJECTIVES: Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized, regional or metastatic adenocarcinoma of the prostate by determining the proportion of patients who experience an objective tumor 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 antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently, patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same dose as before beginning antineoplaston therapy. Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official Title
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Phase II Study of Antineoplastons A10 and AS2-1 Capsules With Total Androgen Blockade in Patients With Stage III or IV Adenocarcinoma of the Prostate

Conditions
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Adenocarcinoma of the Prostate, Stage III Prostate Cancer, Stage IV Prostate Cancer, Recurrent Prostate Cancer

Intervention / Treatment
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* Drug: antineoplaston A10
* Drug: antineoplaston AS2-1
* Drug: bicalutamide
* Drug: flutamide
* Drug: leuprolide acetate
* Procedure: alternative product therapy
* Procedure: antiandrogen therapy
* Procedure: biological therapy
* Procedure: biologically based therapies
* Procedure: cancer prevention intervention
* Procedure: complementary and alternative therapy
* Procedure: differentiation therapy
* Procedure: endocrine therapy
* Procedure: hormone therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven localized, regional, or metastatic adenocarcinoma of the prostate Progressive disease during prior hormonal therapy (both antiandrogen and gonadotropin-releasing hormone) and must continue hormonal therapy Measurable tumors or tumor markers Bone metastases allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: No hepatic failure Bilirubin no greater than 2.5 mg/dL SGOT no greater than 2 times normal Renal: No chronic renal failure 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 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 infections or fever No other prior or concurrent second malignancy within the past 2 years PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: At least 4 weeks since prior investigational clinical trial No other concurrent treatment for metastatic prostate cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antineoplaston A10|nan|
|Drug: antineoplaston AS2-1|nan|
|Drug: bicalutamide|nan|
|Drug: flutamide|nan|
|Drug: leuprolide acetate|nan|
|Procedure: alternative product therapy|nan|
|Procedure: antiandrogen therapy|nan|
|Procedure: biological therapy|nan|
|Procedure: biologically based therapies|nan|
|Procedure: cancer prevention intervention|nan|
|Procedure: complementary and alternative therapy|nan|
|Procedure: differentiation therapy|nan|
|Procedure: endocrine therapy|nan|
|Procedure: hormone therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |