Trial Information

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

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

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

Inclusion Criteria:

• Patients must have a biopsy proven diagnosis of chronic myelogenous leukemia. Patients who were previously treated with chemotherapy, immunotherapy, or cytodifferentiation therapy are eligible. Patients for whom established regimens do not exist or who are unlikely to respond to existing regimens and were treated before are eligible.
• Patients must have measurable disease by physical examination or peripheral blood and bone marrow study, WBC over 20 x 103/mm3 with 20% or less immature myeloid cells in peripheral blood and 30% or less in the bone marrow.
• Patients must be 18 years of age or older and have read, understood, and signed an Informed Consent Form (Appendix A).
• 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.
• Patients are unlikely to respond to existing therapeutic regimens or for whom the curative therapeutic regimens do not exist.
• 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 WBC over 20 x 103/mm3 on presentation, platelet count > 50 x 103/mm3.
• Patients must have no evidence of hepatic insufficiency or renal insufficiency, a total; bilirubin within normal range and creatinine concentration in serum not higher than 2.5 mg/dL; SGOT and SGPT no higher than 5 times the upper limit.
• Patients must recover from the adverse effect of previous therapy. At least 8 weeks must have elapsed 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 should be excluded.
• Patients should have received at least one standard first line treatment for chronic myelogenous leukemia (alpha-interferon or hydroxyurea), with failure of the regimen, before they are enrolled on this study. For patients 45 years of age or younger, the option of chemotherapy with bone marrow transplantation (or peripheral stem cell transplantation) will be discussed.
• 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.