Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients

Sponsor

Eisai Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00050999

Collaborator

(none)

195

Enrollment

Locations

138

Duration (Months)

5.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, T-Cell, Cutaneous Mycosis Fungoides Sezary Syndrome	Drug: ONTAK	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25

Study Start Date :

Jun 1, 1995

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Objective Rate of Response (ORR), defined as CR + CCR + PR []

Secondary Outcome Measures

Time-to-Treatment Failure []
Time-to-Progression []
Duration of Response []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab;
Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;
Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.
Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.
Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.
No systemic infections;
Willingness to be randomized to a placebo treatment only arm;
ECOG performance status 0 or 1;

Exclusion Criteria:

• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas, M.D. Anderson Cancer Center	Houston	Texas	United States	77030
2	Level 4 Department of Haematology Royal North Shore Hospital	St. Leonard's	New South Wales	Australia	2065
3	Westmead Hospital, Department of Haematology	Westmead	New South Wales	Australia	2145
4	Mater Misericordiae Adult Hospital	South Brisbane	Queensland	Australia	4101
5	Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
6	LKH Universitatsklinikum Graz	Graz		Austria	A-8036
7	Allgemeines Krankenhaus der Stadt Wien	Vienna		Austria	A-1090
8	Cross Cancer Centre	Edmonton	Alberta	Canada
9	Hamilton Regional Cancer Center	Hamilton	Ontario	Canada
10	Jewish General Hospital	Montreal	Quebec	Canada
11	Universitatsklinikum Charite	Berlin		Germany
12	University of Erlangen	Erlangen		Germany	91052
13	Universitatsklinikum Essen	Essen		Germany	45122
14	J.W. Goethe University Frankfurt	Frankfurt		Germany	60590
15	Universitatskrankenhaus Eppendorf	Hamburg		Germany	20246
16	Universitatsklinikum Mannheim	Mannheim		Germany	68135
17	Universitatsklinikum Munster	Munster		Germany	D-48149
18	Sektion Dermatologische Onkologie	Tubingen		Germany	D-72076
19	LUMC, Department of Dermatology	Leiden		Netherlands	2333 ZA
20	Medical Academy in Gdansk, Dept. of Hematology	Gdansk		Poland	80-952
21	Regional Oncological Center, Dept. of Chemotherapy	Lodz		Poland	93-509
22	Klinika Hematoonkologii Akademii Medycznej w Lublinie	Lublin		Poland	20-950
23	Oddzial Chorob Wewnetrznych i Hematologii	Poznan		Poland	61-833
24	The Medical University of Warsaw, Central Clinical Hospital	Warsaw		Poland	02-097
25	Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie	Warsaw		Poland	02-781
26	Blokhin Russian Cancer Research Center, RAMS	Moscow		Russian Federation
27	Burdenko Main Military Clinical Hospital	Moscow		Russian Federation
28	Central Research Institute of Skin and Venereal Diseases	Moscow		Russian Federation
29	Haematology Research Center RAMS	Moscow		Russian Federation
30	Samara Regional Clinical Hospital	Samara		Russian Federation	443095
31	St. Petersburg Pavlov State Medical University	St. Petersburg		Russian Federation
32	Universitatsspital Zurich Dermatologische Klinik	Zurich		Switzerland
33	St. John's Institute of Dermatology	London		United Kingdom
34	City Hospital	Nottingham		United Kingdom
35	Southampton General Hospital	Southampton		United Kingdom