Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL)

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma patients.

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

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Boryung Pharmaceutical Co., Ltd
• Treatments: Cytarabine; Etoposide; Etoposide phosphate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Oxaliplatin; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Previously histologically confirmed aggressive lymphomas, defined according to WHO classification (except Burkitt's lymphoma, lymphoblastic lymphoma)

• Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease

• Performance status (ECOG) ≤3

• Age ≤ 75

• Treated with at least one CHOP or CHOP-derived doxorubicin containing regimen

• At least one or more uni-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination

• Adequate organ functions defined as; ANC > 1,500/ul, platelet > 75,000/ul, transaminases < 3 X upper normal values; bilirubin < 2 mg%

• Written informed consent approved by Institutional Review Board

Exclusion Criteria:

• Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix

• Serious co-morbid diseases

• Pregnancy or breast-feeding