A Multicenter Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Patients With Refractory or Relapsed Hodgkin's Lymphoma (HL)
Inclusion Criteria:
- Previously histologically confirmed Hodgkin's lymphoma
- Failure to achieve a complete remission with the initial induction chemotherapy, or
recurrent disease
- Performance status (ECOG) ≤ 3
- Age ≤ 75 years old
- Number of prior chemotherapies: one or two regimens
- 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/dL
- Written informed consent approved by institutional review board or ethic committee
Exclusion Criteria:
- Previous high dose chemotherapy with autologous stem cell transplantation or
allogeneic stem cell transplantation
- Previous chemotherapies with ESHAP regimen
- Any other malignancies within the past 5 years except skin basal cell carcinoma or
carcinoma in situ of cervix
- Other serious illness or medical conditions
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months
prior to study entry
- History of significant neurologic or psychiatric disorders including dementia or
seizures
- Active uncontrolled infection (viral, bacterial or fungal infection)
- Other serious medical illnesses
- Pregnancy or breast-feeding, women of childbearing potential not employing adequate
contraception
- Previous history of drug allergy to one of the drugs in the study regimen