Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Refractory or Relapsed Hodgkin's Lymphoma (HL)

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of combination chemotherapy with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (ESHAOx) for patients with refractory or relapsed Hodgkin's lymphoma (HL).

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

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborators: Asan Medical Center; Severance Hospital
• Treatments: Cytarabine; Etoposide; Etoposide phosphate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Oxaliplatin; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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