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Study on the Combination Regimen of Dexamethasone Ifosfamide Cisplatin Etoposide in Patients With NK/T Cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00568607
First received: December 5, 2007
Last updated: September 7, 2010
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.


Condition Intervention Phase
Lymphoma
 Drug: IFO, VP-16, DDP, DXM
 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 a Combination Chemotherapy of DICE in the Patients With NK/T Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Response rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TTP and OS [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFO, VP-16, DDP, DXM Drug: IFO, VP-16, DDP, DXM
DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 75 mg/m2 d1-4; DDP 20mg/m2 d1-4; q3w. Efficacy was evaluated every two cycles. If patients hadn't diseases progression, two more cycles and radiation would be administered.
Other Name: DICE

Detailed Description:

Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP.The investigators did this trial to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range 18-75 years old
  • Histological confirmed NK/T cell lymphoma
  • ECOG performance status less than 2
  • Life expectancy of more than 3 months
  • None of major drugs in the trial (IFO,VP16,DDP) has been previously used
  • Normal laboratory values: hemoglobin > 80 g/dl, neutrophil > 2×109/L, platelet > 100×109/L, serum creatine < 1.5×upper limitation of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN

Exclusion Criteria:

  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection
  • The evidence of CNS metastasis
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568607

Contacts
Contact: Ye Guo, MD 862164175590 ext 3252 pattrick_guo@msn.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Biyun Wang, MD     8613701748410     wangbiyun@msn.com    
Sub-Investigator: Biyun Wang, M.D.            
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, M.D. Fudan University
  More Information

No publications provided

Responsible Party: Base for Drug Clinical Trials, Fudan University Cancer Hospital, Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT00568607     History of Changes
Other Study ID Numbers: DICE-NK/T
Study First Received: December 5, 2007
Last Updated: September 7, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
NK/T cell lymphoma
Response Rate
TTP
OS
Toxicities

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Etoposide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013