Study on the Combination Regimen of Dexamethasone Ifosfamide Cisplatin Etoposide in Patients With NK/T Cell Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fudan University.
Recruitment status was Recruiting
Information provided by:
First received: December 5, 2007
Last updated: September 7, 2010
Last verified: September 2010
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.
Drug: IFO, VP-16, DDP, DXM
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of a Combination Chemotherapy of DICE in the Patients With NK/T Cell Lymphoma
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2010 (Final data collection date for primary outcome measure)
Experimental: IFO, VP-16, DDP, DXM
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.
Other Name: DICE
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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00568607
|Fudan University Cancer Hospital
|Shanghai, Shanghai, China, 200032 |
|Contact: Biyun Wang, MD 8613701748410 firstname.lastname@example.org |
|Sub-Investigator: Biyun Wang, M.D. |
||Ye Guo, M.D.
No publications provided
||Base for Drug Clinical Trials, Fudan University Cancer Hospital, Fudan University Cancer Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 5, 2007
||September 7, 2010
||China: Ethics Committee
Keywords provided by Fudan University:
NK/T cell lymphoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2014
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Molecular Mechanisms of Pharmacological Action