Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas
- Histological or cytological diagnosis of non-Hodgkin's lymphoma
- Disease exclusively localised into the CNS at first diagnosis and failure
- Progressive or recurrent disease
- Previous treatment with HDMTX containing CHT and/or RT
- Presence of at least one target lesion, bidimensionally measurable
- Age 18 - 75 years
- ECOG performance status < 3 (Appendix 1).
- No known HIV disease or immunodeficiency
- HBsAg-negative and Ab anti-HCV-negative patients.
- Adequate bone marrow function (plt > 100000 mm3, Hb > 9 g/dl, ANC > 2.000 mm3)
- Adequate renal function (serum creatinine < 2 times UNL)
- Adequate hepatic function (SGOT/SGPT < 3 times UNL, bilirubin and alkaline
phosphatase < 2 times UNL)
- Adequate cardiac function (VEF ≥ 50%)
- Absence of any psycological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule
- Non-pregnant and non-lactating status for female patients. Adequate contraceptive
measures during study participation for sexually active patients of childbearing
- No previous or concurrent malignancies at other sites with the exception of
surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma
of the skin and of other neoplasms without evidence of disease since at least 5
- No concurrent treatment with other experimental drugs.
- Informed consent signed by the patient before registration