Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma

Lymphoma, T-Cell Clinical Trial

Official title:

A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418535
• Other study ID #: 2004-10-08
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2007
• Last updated: October 20, 2009
• Start date: April 2006
• Est. completion date: July 2009

Study information

• Verified date: January 2007
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory.

The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed NK/T-cell lymphoma

• Localized (Ann Arbor stage I/II) disease

• At least one measurable lesion

• Age > 18

• ECOG performance status 0 - 2

• Expected life span of at least 12 weeks

• Normal marrow function (hemoglobin = 9.0 g/dL; absolute neutrophil count = 1,500/mm3; platelet count = 100,000/mm3)

• Normal liver function (total bilirubin < 2x upper limit of normal [ULN], transaminase < 3x ULN)

• Normal renal function (serum creatinine = 1.5 mg/dL, creatinine clearance = 50 mL/min)

• Written informed consent

Exclusion Criteria:

• Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ

• Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)

• Acute or active infection requiring intravenous (IV) antibiotics

• Pregnant, lactating women

• Previous history of chemotherapy or radiotherapy

• Concomitant medication that may influence the study drugs

• Allergic reaction to study drugs

• Grade 2 or greater peripheral neuropathy

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell

Intervention

Drug:
• Concurrent Radiotherapy (RT)/cisplatin, VIPD

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Samsung Medical Center	Asan Medical Center, Gyeongsang National University Hospital, Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of,