Prostate Cancer Clinical Trial
Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer
Summary
Current therapies for Refractory 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 Refractory Stage IV Prostate Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Refractory Stage IV Prostate Cancer.
Full Description
Refractory Stage IV Prostate Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
To determine the efficacy of Antineoplaston therapy in patients with Refractory 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 Refractory Stage IV Prostate Cancer.
To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed incurable stage IV adenocarcinoma of the prostate that failed to respond to treatment with antineoplaston A10 and AS2-1 capsules and for which no curative therapy exists
Evidence of tumor by MRI or CT scan
No prostate-specific antigen (PSA) response to antiandrogen withdrawal
If PSA changes used to indicate progressive disease, then PSA must increase more than 50% on two determinations at least 2 weeks apart
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Karnofsky 60-100%
Life expectancy:
At least 2 months
Hematopoietic:
Hemoglobin at least 9 g/dL
WBC at least 2000/mm^3
Platelet count at least 50,000/mm^3
Hepatic:
No hepatic insufficiency
Bilirubin no greater than 2.5 mg/dL
SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
Creatinine no greater than 2.5 mg/dL
No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
No known chronic heart failure
No uncontrolled hypertension
No history of congestive heart failure
No history of other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
No serious lung disease, such as severe chronic obstructive pulmonary disease
Other:
Fertile patients must use effective contraception during and for 4 weeks after study participation
Not a high medical or psychiatric risk
No concurrent nonmalignant systemic disease that would preclude therapy
No active infection
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:
See Disease Characteristics
At least 4 weeks since prior hormonal therapy and recovered
Concurrent corticosteroids allowed if dose is stable or decreasing
Radiotherapy:
At least 4 weeks since prior radiotherapy and recovered
Surgery:
Recovered from prior surgery
Other:
Prior cytodifferentiating agents allowed
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There is 1 Location for this study
Houston Texas, 77055, United States
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