Clinical trial NCT00336583: Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL)
Official title: Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOX) for Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: oxaliplatin
ESHAOX
refractory
relapsed
non-hodgkin's lymphoma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Boryung Pharmaceutical Co., Ltd
First posted: 2006-06-14
Enrollment: 27
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients with aggressive non-Hodgkin's lymphoma (NHL) are known to have a malignancy considered curable in many cases. However, diagnosis of refractory or relapsed disease is devastating and the treatment is difficult because regimens of chemotherapy used as salvage therapy are available only in limited numbers. ESHAP, consisting of etoposide, methylprednisolone, high-dose cytarabine and cisplatin, is one of commonly used salvage regimen, and showed its efficacy and feasibility. But it often requires discontinuation of the treatment due to its myelosuppression, neuropathy and renal toxicity, which can also impede further treatment. Oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin, and was reported to be active in patients with NHL as a single agent. In addition, the substitution of cisplatin by oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL, showed meaningful anti-tumor activity with favorable toxicity profile. Based on preclinical and clinical findings, we will conduct a multi-center phase II study of ESHAOX, which substitutes oxaliplatin with cisplatin in the ESHAP regimen, to evaluate the efficacy and toxicity profile in patients with recurrent or refractory NHL.

Eligibility 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Worst Toxicity Grade by Patient
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Cheolwon Suh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sym SJ, Lee DH, Kang HJ, Nam SH, Kim HY, Kim SJ, Eom HS, Kim WS, Suh C. A multicenter phase II trial of etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin for patients with primary refractory/relapsed aggressive non-Hodgkin's lymphoma. Cancer Chemother Pharmacol. 2009 Jun;64(1):27-33. doi: 10.1007/s00280-008-0847-y. Epub 2008 Oct 7.