Trial Information

Summary: Phase II Study Of Antineoplaston A10 And AS2-1 In Patients With Mantle Zone Lymphoma

Study the safety and possible effectiveness of antineoplastons in serious or immediately life-threatening Mantle Zone Lymphoma.

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

Inclusion Criteria:

• Patients must have a biopsy proven Stage II to IV, Mantle Zone Lymphoma, that is not curable by surgery, radiotherapy, and/or chemotherapy, and are not likely to obtain substantial benefit from available standard therapies.
• 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.
• 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 > 2000/mm3 on presentation and a platelet count > 50,000/m3.
• The patient must have a normal total bilirubin and creatinine level.
• The patient must have recovered from the adverse effects of previous therapy; at least 8 weeks must have elapsed since the last dose of radiation therapy and at least 4 weeks must be elapsed since the last dose of chemotherapy (six weeks for nitrosoureas) or immunotherapy.
• Enrollment will be restricted to patients with intermediate grade non-Hodgkin’s lymphoma that has not responded to, or has relapsed following, a standard primary treatment chemotherapy regimen plus at least one standard second-line "salvage" chemotherapy regimen

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, and/or other corticosteroids should be prohibited for a minimum of four weeks prior to baseline staging and for duration of the study.
• The patients with hypertension, history of congestive heart failure, or history of cardiovascular 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.