Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336583
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2006-06-13
Brief Title:
Etoposide Methylprednisolone High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkins Lymphoma NHL
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Phase II Study of Etoposide Methylprednisolone High-dose Cytarabine and Oxaliplatin ESHAOX for Patients With Refractory or Relapsed Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-Hodgkins lymphoma patients
Detailed Description:
Patients with aggressive non-Hodgkins 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 12-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None