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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00568607
• Other study ID #: DICE-NK/T
• Status: Recruiting
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: September 7, 2010
• Start date: March 2007
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: Fudan University
• Contact: Ye Guo, MD
• Phone: 862164175590
• Email: pattrick_guo[@]msn.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		every two cycles	No
Secondary	TTP and OS		every two cycles	No