Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve similar survival outcomes but with reduced neurotoxicity compared to regimens using methotrexate with high dose radiotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Collaborator: Australasian Leukaemia and Lymphoma Group
• Treatments: Idarubicin; Lenograstim; Methotrexate

Criteria

Inclusion Criteria:

• Histologically proven primary CNS lymphoma.

• Absence of disease outside the CNS.

• ECOG performance status 0-3

• Negative HIV status.

• Peripheral blood counts with granulocytes >1.5 x 109L and platelets > 100 x 109L. Serum creatinine <150mmol/L. Serum bilirubin <1.5 times and AST <2 times upper limit of normal.

• Age >18 and <=70 years.

• Patients must give written informed consent.

• Corticosteroids prior to histological diagnosis are allowed.

Exclusion Criteria:

• Previous history of malignancy (other than non-melanomatous skin carcinoma, or carcinoma in situ of cervix completely excised).

• Patients who are pregnant or lactating.

• NYHA (New York State Heart Association classification) cardiac failure grade 3

• Macroscopic spinal thecal or spinal cord disease.