Study on the Combination Regimen of Dexamethasone Ifosfamide Cisplatin Etoposide (DICE) in Patients With NK/T Cell Lymphoma - Full Text View

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00568607

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 II

MedlinePlus related topics: Lymphoma

Drug Information available for: Mesna Ifosfamide Etoposide Cisplatin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of a Combination Chemotherapy of DICE in the Patients With NK/T Cell Lymphoma

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 2008

Arms	Assigned Interventions
A: Experimental	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.

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.We 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

8613501678472

pattrick_guo@msn.com

Locations

China
Fudan University Cancer Hospital	Recruiting
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 Cancer Hospital

More Information

Responsible Party:	Fudan University Cancer Hospital ( Base for Drug Clinical Trials, Fudan University Cancer Hospital )
Study ID Numbers:	DICE-NK/T
Study First Received:	December 5, 2007
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00568607
Health Authority:	China: Ethics Committee

Keywords provided by Fudan University:

NK/T cell lymphoma
Response Rate
TTP

OS
Response Rate
Toxicities

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Etoposide phosphate
Lymphatic Diseases
Ifosfamide
Cisplatin
Lymphoma, T-Cell

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Etoposide
Mesna
Dexamethasone acetate
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009