Phase I/II Study of Concurrent Chemoradiotherapy for Newly-Diagnosed, Localized Nasal NK/T-Cell Lymphoma: Results of a Phase I Portion of JCOG0211-DI

Aim:
To explore a more effective treatment for newly-diagnosed localized nasal NK/T-cell lymphoma, we conducted a multicenter phase I/II study of concurrent chemoradiotherapy.

Conclusions:
Researchers concluded results suggest that concurrent chemoradiotherapy using MDR-
non-related agents and ETP is a promising treatment strategy for localized nasal NK/T-cell lymphoma.

Official Title

Conditions

Study Type

Phase I/II Study

Study Design

Pts with newly-diagnosed, localized (IE and contiguous IIE with cervical node involvement) diseases, 20-69 years of age and PS 0-2.Enrolled 10 pts showed the following features: – age 30-61 yrs (median 44.5), M_F=5:5- Stage IE 6, stage IIE 4,- B symptom(+) 4, elevated serum LDH 2- PS0 6, PS1 4

Further Details

Treatment:Concurrent chemoradiotherapy consisted of 50 Gy of RT + 3 courses of DeVIC chemotherapy :carboplatin (CBDCA) 300mg/m2 d1 IV, etoposide (ETP) 100mg/m2 d1-3 IV, ifosfamide (IFM) 1.5g/m2 d1-3 IV, dexamethasone (DMS) 40mg/body d1-3 IV; every 21 days].In the phase I portion, a standard 3+3 design was used to evaluate dose-limiting toxicities (DLTs). The doses of RT and DMS were fixed. Two dose levels of CBDCA/ETP/IFM were evaluated: Level 1 (2/3-dose DeVIC) CBDCA 200mg/m2, ETP 67mg/m2, IFM 1.0g/m2 and Level 2 (100%-dose DeVIC).Results:In summary, at Level 1, 1 pt developed PD before evaluation of DLT.Remaining 3 pts did not develop DLT. At Level 2, 4 out of 6 pts developed DLT. Thus, we decided to select the Level 1 for the subsequent phase II portion. Of all 10 enrolled pts, 7 achieved CR, 2 PD, and 1 not evaluable. Of note, all 10 pts achieved local control.

Study Start

Eligibility & Criteria

Indication:Newly-Diagnosed, Localized Nasal NK/T-Cell Lymphoma

Total Enrolment

10

Contact Details

Abstract 2685 ASH 2005Multi center Japan