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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 because the information has not been verified recently.
Verified February 2011 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Asan Medical Center
Severance Hospital
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01300156
First received: February 18, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cytarabine
Etoposide
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Oxaliplatin
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antiviral Agents
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014