New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma
Conditions
Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, T-Cell
Conditions: Keywords
NK/T cell lymphoma, DICE, L-asparaginase
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: L-asp, DXM, IFO, VP-16, DDP
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell lymphoma.
Detailed Description
DICE regimen was found to be highly effective as induction chemotherapy in patients with early stage NK/T-cell lymphoma in the ongoing study. L-asparaginase, an agent with unique anti-cancer mechanism, was also found to be effective in salvage setting. In terms of non-overlapped efficacy and toxicity, the investigators designed this phase II study to verify the efficacy and tolerability of this new combination.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 14 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age range 14-75 years old

- Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract

- ECOG performance status less than 2

- Life expectancy of more than 3 months

- 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
Location
Fudan University Cancer Hospital
Shanghai, Shanghai, China
Status: Recruiting
Contact: Ye Guo, MD - 862164175590 - pattrick_guo@msn.com
Start Date
June 2009
Completion Date
June 2012
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page