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

Primary Purpose

Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

IFO, VP-16, DDP, DXM

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring NK/T cell lymphoma, Response Rate, TTP, OS, Toxicities

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IFO, VP-16, DDP, DXM

Arm Description

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

TTP and OS

Full Information

NCT ID

NCT00568607

First Posted

December 5, 2007

Last Updated

September 7, 2010

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT00568607

Brief Title

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

Official Title

Phase II Study of a Combination Chemotherapy of DICE in the Patients With NK/T Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

NK/T cell lymphoma, Response Rate, TTP, OS, Toxicities

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IFO, VP-16, DDP, DXM

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

IFO, VP-16, DDP, DXM

Other Intervention Name(s)

DICE

Intervention Description

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.

Primary Outcome Measure Information:

Title

Response rate

Time Frame

every two cycles

Secondary Outcome Measure Information:

Title

TTP and OS

Time Frame

every two cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ye Guo, MD

Phone

862164175590

Ext

3252

pattrick_guo@msn.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ye Guo, M.D.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Biyun Wang, MD

Phone

8613701748410

wangbiyun@msn.com

First Name & Middle Initial & Last Name & Degree

Biyun Wang, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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