Prostate Cancer Clinical Trial
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
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.
Full 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.
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
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There is 1 Location for this study
Houston Texas, 77055, United States
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