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

NCT ID: NCT00336583

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-01-31

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.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxaliplatin, response

relapsed or refractory non-Hodgkin's lymphoma

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin, 130 mg per square meter, on day 1

Interventions

Oxaliplatin

Oxaliplatin, 130 mg per square meter, on day 1

Intervention Type: DRUG

Other Intervention Names

etoposide, 40 mg per square meter on days 1 to 4,; methylprednisolone, 500 mg on days 1 to 5,; cytarabine, 2 g per square meter on day 5

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

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

AsanMedical Center, University of Ulsan College of Medicine

Principal Investigators

Cheolwon Suh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: RESULT

PMID: 18839172 (View on PubMed)

Other Identifiers

AMC 2006-130

Identifier Type: -

Identifier Source: org_study_id