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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by National Cancer Center, Korea.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300156
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Asan Medical Center
Severance Hospital
Information provided by:
National Cancer Center, Korea
  Purpose
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).

Condition Intervention Phase
Hodgkin's Lymphoma Drug: Oxaliplatin-based chemotherapy (ESHAOx) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Overall Response rate to ESHAOx chemotherapy [ Time Frame: within 3 weeks after the completion of the treatment ]
    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.


Secondary Outcome Measures:
  • Overall survival, response duration, toxicity profiles [ Time Frame: up to 5 years after the completion of treatment ]

Estimated Enrollment: 37
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESHAOx arm
Patients who are planned to be treated with ESHAOx chemotherapy
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300156


Contacts
Contact: Hyewon Lee, MD +82-31-920-1765 hwlee@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang, Korea, Republic of
Contact: Hyewon Lee, MD    +82-31-920-1765    hwlee@ncc.re.kr   
Principal Investigator: Hyeon Seok Eom, MD, PhD         
Sponsors and Collaborators
National Cancer Center, Korea
Asan Medical Center
Severance Hospital
Investigators
Principal Investigator: Hyeon Seok Eom, MD, PhD National Cancer Center, Korea
  More Information

Responsible Party: Hyeon-Seok Eom / MD, PhD, Natioinal Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01300156     History of Changes
Other Study ID Numbers: NCCCTS-10-524
First Submitted: February 18, 2011
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
Last Verified: February 2011

Keywords provided by National Cancer Center, Korea:
Hodgkin's disease
lymphoma
Relapsed
refractory

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Oxaliplatin
Etoposide phosphate
Etoposide
Cytarabine
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents