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

NCT00568607 | Unknown Phase 2

• 1 other identifier: DICE-NK/T
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response rate

  every two cycles

Secondary Outcomes (1)

• TTP and OS

  every two cycles

Study Arms (1)

IFO, VP-16, DDP, DXM

EXPERIMENTAL

Drug: IFO, VP-16, DDP, DXM

Interventions

IFO, VP-16, DDP, DXM DRUG

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.

Also known as: DICE

IFO, VP-16, DDP, DXM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma; Lymphoma, Extranodal NK-T-Cell

Interventions

Etoposide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Ye Guo, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Guo, MD

CONTACT

862164175590; pattrick_guo@msn.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 8, 2010

Record last verified: 2010-09

Locations

CN (1)