Expired Study
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Houston, Texas 77055


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003534


Primary Contact:

Principal Investigator
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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