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

Study Overview
=================
Brief Summary
-----------------
Current therapies for Stage III or Stage IV Prostate Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage III or Stage IV Prostate Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage III or Stage IV Prostate Cancer.

Detailed Description
-----------------
Stage III or Stage IV Prostate Cancers receive Antineoplaston A10 and AS2-1 capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. OBJECTIVES: To determine the efficacy of Antineoplaston therapy in patients with Stage III or Stage IV Prostate Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). To determine the safety and tolerance of Antineoplaston therapy in patients with Stage III or Stage IV Prostate Cancer. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years thereafter.

Official Title
-----------------
Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Antineoplaston therapy (Atengenal + Astugenal)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antineoplastons<br>Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity. | Drug: Antineoplaston therapy (Atengenal + Astugenal)<br>* Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.<br>* Other names: A10 (Atengenal); AS2-1 (Astugenal);|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage III or Stage IV Prostate Cancer Stage III, Stage III or Stage IV Prostate Cancer Stage IV