Trial Information

Summary: Phase II Study Of Antineoplaston A10 And AS2-1 In Patients With Chronic Lymphocytic Leukemia

Study the safety and possible effectiveness of antineoplastons in serious or immediately life-threatening chronic lymphocytic leukemia.

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

Inclusion Criteria:

• Only patients with a proven diagnosis of advanced stage symptomatic Chronic lymphocytic leukemia refractory to standard chemotherapy including an alkylating agent containing regimen and fludarabine phosphate are eligible.
• Patients must have measurable disease by contrast-enhanced CT scan or MRI performed within 14 days of the beginning of the Treatment. The minimum size of the lesion to be considered malignant and measurable should be more than 2 cm in largest diameter for the lymph nodes located in the head, neck, axillary, inguinal, and femoral areas, and not less than 1cm in the largest diameter for the other locations. Small lesions, 1 to 2 cm in diameter, which cannot be accurately measured on scans, should be excluded form evaluation, but they should be included if they can be measured accurately.
• Patients must be 18 years of age or older and have read, understood, and signed an Informed Consent Form (Appendix B).
• Patients must have a performance status from 60% to 100% on the Karnofsky Performance Scale and a life expectancy of at least two months and be able to comply with an outpatient regimen and follow- up.
• The use of dexamethasone, prednisone or other corticosteroids should be prohibited for a minimum of four weeks prior to baseline staging and for duration of the study.
• Patients may be male or female. If female, the patient must not be pregnant or breast feeding an infant, and either incapable of becoming pregnant or currently using contraceptive methods. Acceptable methods include the birth control pill, use of a diaphragm intrauterine device, or condom by the patient's sexual partner. If male, the patient should use the appropriate contraception such as condoms, during the study and at least 4 weeks following completion of the study.
• Patients must have a white blood cell count > 2,000 mm3 on presentation, platelet count > 50,000 mm3.
• Patients must have no evidence of cardiac or hepatic insufficiency. Patient must have total bilirubin in serum below 2.5-mg/dL and creatinine level below 2.5 mg/dL. SGOT and SGPT not higher than 5 x upper limit.
• Patients must recover from the adverse effect of previous therapy. At least 8 weeks must have lapsed since the last dose of radiation therapy and at least 4 weeks must have elapsed since the last dose of chemotherapy (six weeks for nitrosoureas) or immunotherapy.

EXCLUSION CRITERIA:

• Patients should not have serious active infections requiring concomitant antibiotics, antifungals, or antivirals.
• Patients who are currently receiving a recognized antineoplastic agent or immunomodulatory agent (Interferon, IL-2 etc.) will not be eligible.
• Patients who have had prior Antineoplaston treatment will be excluded
• The use of dexamethasone, prednisone or other corticosteroids should be prohibited for a minimum of four weeks prior to baseline staging and for duration of the study.
• Patients with hypertension, history of congestive heart failure, or history of cardiovascular or renal conditions that contraindicate the administration of high dosages of sodium are not to be enrolled.

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