New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Fudan University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fudan University
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT00933673
First received: July 6, 2009
Last updated: February 16, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: L-asp, DXM, IFO, VP-16, DDP |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II NK/T-cell Lymphoma |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Asparaginase
Etoposide
Etoposide phosphate
Asparaginase erwinia chrysanthemi
U.S. FDA Resources
Further study details as provided by Fudan University:
Primary Outcome Measures:
- complete response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall response rate, PFS and OS [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 76 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: L-DICE |
Drug: L-asp, DXM, IFO, VP-16, DDP
L-asp 6000 u/m2; DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 60 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: L-DICE
|
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.
Eligibility| Ages Eligible for Study: | 14 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933673
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933673
Contacts
| Contact: Ye Guo, MD | 862164175590 | pattrick_guo@msn.com |
Locations
| China, Shanghai | |
| Fudan University Cancer Hospital | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Ye Guo, MD 862164175590 pattrick_guo@msn.com | |
| Principal Investigator: Ye Guo, MD | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | Ye Guo, MD | Fudan University |
More Information
No publications provided
| Responsible Party: | Ye Guo, Dr., Fudan University |
| ClinicalTrials.gov Identifier: | NCT00933673 History of Changes |
| Other Study ID Numbers: | LMTG 09-02 |
| Study First Received: | July 6, 2009 |
| Last Updated: | February 16, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
NK/T cell lymphoma DICE L-asparaginase |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, T-Cell Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders |
Neoplasms Neoplasms by Histologic Type Asparaginase Antineoplastic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015