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

Hodgkin's Lymphoma Clinical Trial

Official title:

A Multicenter Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Patients With Refractory or Relapsed Hodgkin's Lymphoma (HL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01300156
• Other study ID #: NCCCTS-10-524
• Status: Recruiting
• Phase: Phase 2
• First received: February 18, 2011
• Last updated: February 18, 2011
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2011
• Source: National Cancer Center, Korea
• Contact: Hyewon Lee, MD
• Phone: +82-31-920-1765
• Email: hwlee[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• Oxaliplatin-based chemotherapy (ESHAOx)
Etoposide 40 mg/m2, D1-4 Methylprednisolone 500mg, D1-5 Cytarabine 2 g/m2, D5 Oxaliplatin 130 mg/m2, D1

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang

Sponsors (3)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Asan Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response rate to ESHAOx chemotherapy	To evaluate response rate by Cheson criteria for malignant lymphoma after 3 and 6 cycles of treatment with ESHAOx regimen in patients with refractory or relapsed Hodgkin's lymphoma.	within 3 weeks after the completion of the treatment	No
Secondary	Overall survival, response duration, toxicity profiles		up to 5 years after the completion of treatment	Yes