Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: Oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOX) for Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma |
- Overall Response Rate [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]The Overall Response Rate is measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response will be evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
- Worst Toxicity Grade by Patient [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]graded by National Cancer Institute Common Toxicity Criteria of Adeverse Event version 3.0
| Enrollment: | 27 |
| Study Start Date: | June 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oxaliplatin, response
relapsed or refractory non-Hodgkin's lymphoma
|
Drug: Oxaliplatin
Oxaliplatin, 130 mg per square meter, on day 1
Other Names:
|
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| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Korea, Republic of | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
| Principal Investigator: | Cheolwon Suh, MD, PhD | Asan Medical Center |
More Information
Publications:
| Responsible Party: | Suh, Cheolwon, AsanMedical Center, University of Ulsan College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00336583 History of Changes |
| Other Study ID Numbers: | AMC 2006-130 |
| Study First Received: | June 13, 2006 |
| Results First Received: | May 5, 2009 |
| Last Updated: | May 25, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Asan Medical Center:
|
oxaliplatin ESHAOX refractory relapsed non-hodgkin's lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Etoposide phosphate Oxaliplatin Etoposide Methylprednisolone Hemisuccinate Prednisolone Methylprednisolone acetate |
Prednisolone acetate Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013