Trial Information

Summary: Phase II Study Of Antineoplastons A10 And AS2-1 In Patients With Adenocarcinoma Of The Prostate

Provide the treatment for incurable adenocarcinoma of the prostate for patients who failed to respond to treatment with Antineoplaston A10 and AS2-1 capsules.

Describe the patients' response, tolerance to, and the side effects of this regimen.

Inclusion Criteria:

• Patients should have histologically confirmed incurable adenocarcinoma of the prostate, Stage D2 that failed to respond to the treatment with Antineoplaston A10 and AS2-1 capsules for which the curative therapeutic regimens do not exist.
• There will be no exclusion based on tumor size or systemic metastases.
• Radiologic evidence of tumor by gadolinium-enhanced MRI or contrast-enhanced CT scan, chest x-ray, or radionuclide scan, if necessary, performed within 14 days before initiating the treatment.
• Patients who have previously received radiation therapy, chemotherapy, immunotherapy or cytodifferentiating agent including Antineoplaston A10 and AS2-1 capsules are eligible.
• Patients who did not receive standard therapy are eligible.
• If sexually active men, the patient should use appropriate contraception, such as condoms, during the study and at least 4 weeks following completion of the study.
• Patients must be 18 years of age or older.
• Patient must sign the Informed Consent Form indicating an awareness of the experimental nature of this study. In the event that the patient has impairment of higher intellectual function, example aphasia, then the patient's legal next of kin or legal guardian must sign the Informed Consent Form indicating an awareness of the experimental nature of the study (Appendix B).
• Patient must fully recover from the operative procedure and have life expectancy of two months or more. The patient's Performance Status should be consistent with outpatient therapy, i.e. 60% to 100% Karnofsky. The use of corticosteroids is permitted, if necessary. It is recommended that the smallest dose be used and recorded. Patients on a stable or decreasing dose of corticosteroids for at least two months may be eligible for the study. However, patients requiring intimation of corticosteroids or increase in the dose of corticosteroids prior to entry, should not be enrolled. A patient requiring the administration of corticosteroids or an increase in the dose of corticosteroids during the study is no longer accessible for tumor response and should be considered to have tumor progression.
• Minimal hematological parameters include hemoglobin of at least 9g/dL, a white blood count of at least 2,000/mm3 and a platelet count of at least 50,000/mm3.
• Patients must have no evidence of hepatic insufficiency, total bilirubin within normal limits, and SGOT and SGPT not higher than five times the upper limit. Creatinine concentration in serum should not exceed 2.5mg/dL.
• Patients must recover from the adverse effect of previous therapy. At least four weeks must have elapsed since the last dose of radiation therapy and/or the last dose of chemotherapy, immunotherapy or hormonal therapy. In patients in whom an antiandrogen has been discontinued, the possibility of a response to the antiandrogen withdrawal must be considered and evaluated. This requires a PSA level at the time of withdrawal, which presumably shows progression unless progression was shown by some other criterion, and PSA levels 2 weeks and 4 weeks after antiandrogen (2 weeks, 4 weeks, and 7 weeks after Casodex) discontinuation, to show there was not a PSA response to the antiandrogen withdrawal.
• If PSA changes are used, as indicators of progressive disease, the level of PSA should show a significant increase (more than 50%) confirmed on two consecutive determinations at least two weeks apart
• Patients with multiple tumors, who have received radiation therapy to some but not all of their tumors, may be admitted earlier than four weeks from the last dose of radiation therapy.

EXCLUSION CRITERIA:

• Failure to meet all inclusion criteria.
• Patient is a high medical or psychiatric risk, having non-malignant systemic disease which would, in the opinion of the investigator, make therapy with an investigational drug unwise.
• Patient is incompetent to give his informed consent to treatment. However, the patient may be admitted if a legally appointed guardian gives consent.
• Presence of active infection.
• Patients with known chronic heart failure and serious lung disease, such as severe COPD.
• Patients with hypertension are excluded unless the blood pressure is adequately controlled. Patients who have had prior antineoplaston treatment should be excluded from this protocol.
• Patients who do not have adequate hepatic function.
• Due to the sodium content in antineoplaston formulation, the patients with hypertension, history of congestive heart failure, or history of cardiovascular or renal conditions that medically contraindicate administration of high dosages of sodium are not to be enrolled on treatment.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.