Trial | NCT00418535  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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.
Study Started
Apr 30
2006
Primary Completion
Mar 31
2009
Study Completion
Jul 31
2009
Last Update
Oct 21
2009
Estimate

Drug Concurrent Radiotherapy (RT)/cisplatin, VIPD

Criteria 

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
No Results Posted