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

NCT00418535 | Completed Phase 2

• 1 other identifier: 2004-10-08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma, T-Cell

Keywords

Lymphoma, NK/T-Cell

Interventions

Concurrent Radiotherapy (RT)/cisplatin, VIPD DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korea University Anam Hospital: collaborator
• Asan Medical Center: collaborator
• Gyeongsang National University Hospital: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Won Seog Kim, MD, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

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: January 3, 2007
• First Posted: January 5, 2007
• Study Start: April 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 21, 2009

Record last verified: 2007-01

Locations

KR (1)