Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma(MZL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Samsung Medical Center
Asan Medical Center
Chung-Ang University
Kyungpook National University
Chonnam National University Hospital
Korea Cancer Center Hospital
Korea University
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital
ClinicalTrials.gov Identifier:
NCT01068392
First received: February 11, 2010
Last updated: May 5, 2012
Last verified: May 2012
  Purpose

The investigators are willing to investigate the efficacy and safety of oxaliplatin and prednisolone (Ox-P) combination in patients with previously treated MZL who have a few clinical trial data.


Condition Intervention Phase
B-cell Lymphomas
Drug: Oxaliplatin, Prednisolone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Dong-A University Hospital:

Primary Outcome Measures:
  • Response rate by International Working Group Response Criteria [ Time Frame: 6 month after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 3 year after start ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 5 year after start ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: October 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OXP
Oxaliplatin 130mg/m2 + 5DW 500ml MIV over 2HR D1 Prednisolone 100mg/Day D1-D5 Every 3 weeks Maximum 6 cycles of treatment will be given for this study. Subjects will be treated for at least 1 cycle and to a maximum of 6 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent.
Drug: Oxaliplatin, Prednisolone

OXALIPLATIN+PREDNISOLONE (OX-P)

D1 Oxaliplatin 130mg/m2 + 5DW 500ml MIV over 2hr

D1-5 Prednisolone 40-30-30 mg/day P.O

every 3 weeks


Detailed Description:

Over its long survival duration, MZL often involves frequent relapses. Overall, more than 50% of MZL patients experience a relapse within 10 years. However, Relapsed or refractory MZL represent a therapeutic dilemma in every day clinical practice and no prospective studies on large series have been published so far. The rarity of these disorders and some difficulties in the differential diagnosis from other low-grade lymphoma subtypes are obstacles in conducting epidemiological surveys and in properly describing clinical features and outcomes.

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 antitumor activity with favourable toxicity profile.

In the previous phase II study of oxaliplatin for treatment of patients with mucosa-associated lymphoid tissue lymphoma, a total of 16 patients with MALT lymphoma of various sites of origin (four of the ocular adnexa, five of the salivary glands, three of the stomach, two of the lung, and one of the colon and the breast) were administered oxaliplatin at a dose of 130 mg/m2 infused during 2 hours every 3 weeks. Fifteen patients responded to chemotherapy, with nine achieving CR (56%), six (37.5%) achieving partial response, and one achieving stable disease; the median time to response was 4 months (range; 2 to 4 months).

Based upon the promising results of oxaliplatin regimen in refractory NHL and first-line treatment of MZL, The investigators are willing to investigate the efficacy and safety of oxaliplatin and prednisolone (Ox-P) combination in patients with previously treated MZL who have a few clinical trial data.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed marginal zone B-cell lymphomas
  • Failure to achieve a clinical benefit (≥SD) with the initial treatment, or recurrent disease
  • Performance status (ECOG) ≤2
  • Age ≥ 20
  • At least one or more bi-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 kidney functions defined as; Cr < 2.0 mg% or Ccr > 60 ml/min
  • Adequate liver functions defined as; Transaminases < 3 X upper normal values; Bilirubin < 2 mg%
  • Adequate bone marrow functions defined as; ANC > 1500/㎕, platelet > 75000/㎕
  • Ann Arbor stage III or IV
  • Ann Arbor stage I or II, which is not adequate for RT or surgical approach (e.g. multiple lung lesions, multiple colon involvement, remote abdominal LN with stomach involvement)
  • Written informed consent approved by Institutional review board or Ethic committee

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
  • Previous history of drug allergy to one of the drugs in the study regimen
  • During this study duration, patients who take other clinical trial medication, chemotherapy, hormonal therapy, or immunotherapy
  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: NCT01068392

Locations
Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of, 602-715
Sponsors and Collaborators
Dong-A University Hospital
Samsung Medical Center
Asan Medical Center
Chung-Ang University
Kyungpook National University
Chonnam National University Hospital
Korea Cancer Center Hospital
Korea University
Investigators
Principal Investigator: Cheolwon Suh, M.D., Ph.D. Asan Medical Center
Study Director: Sung Yong Oh, M.D., Ph.D. Dong-A University
  More Information

No publications provided

Responsible Party: Sung Yong Oh, Department of internal medicine, Dong-A University Hospital
ClinicalTrials.gov Identifier: NCT01068392     History of Changes
Other Study ID Numbers: CISL-MZL-10-3
Study First Received: February 11, 2010
Last Updated: May 5, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Dong-A University Hospital:
relapsed
marginal zone B-cell lymphoma
oxaliplatin
prednisolone

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Oxaliplatin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014