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

Sponsor

Eisai Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00051012

Collaborator

(none)

Enrollment

Locations

135

Duration (Months)

2.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.

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

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25

Study Start Date :

Sep 1, 1995

Actual Primary Completion Date :

Oct 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:

Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
CTCL disease Stage Ia - III.
History of less than or equal to 3 previous 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 chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
No systemic infections.
ECOG performance status of 0 or 1.

Exclusion Criteria:

• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.

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	Peter MacCallum Cancer Institute	Melbourne	Victoria	Australia	3002
7	LKH Universitatsklinikum Graz	Graz		Austria	A-8036
8	Allgemeines Krankenhaus der Stadt Wien	Vienna		Austria	A-1090
9	Cross Cancer Centre	Edmonton	Alberta	Canada
10	Hamilton Regional Cancer Center	Hamilton	Ontario	Canada
11	Jewish General Hospital	Montreal	Quebec	Canada
12	Universitatsklinikum Charite	Berlin		Germany
13	University of Erlangen	Erlangen		Germany	91052
14	Universitatsklinikum Essen	Essen		Germany	45122
15	J.W. Goethe University Frankfurt	Frankfurt		Germany	60590
16	Universitatskrankenhaus Eppendorf	Hamburg		Germany	20246
17	Universitatsklinikum Mannheim	Mannheim		Germany	68135
18	Universitatsklinikum Munster	Munster		Germany	D-48149
19	Medical Academy in Gdansk, Dept. of Hematology	Gdansk		Poland	80-952
20	Regional Oncological Center, Dept. of Chemotherapy	Lodz		Poland	93-509
21	Klinika Hematoonkologii Akademii Medycznej w Lublinie	Lublin		Poland	20-950
22	Oddzial Chorob Wewnetrznych i Hematologii	Poznan		Poland	61-833
23	The Medical University of Warsaw, Central Clinical Hospital	Warsaw		Poland	02-097
24	Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie	Warsaw		Poland	02-781
25	Blokhin Russian Cancer Research Center, RAMS	Moscow		Russian Federation
26	Burdenko Main Military Clinical Hospital	Moscow		Russian Federation
27	Central Research Institute of Skin and Venereal Diseases	Moscow		Russian Federation
28	Haematology Research Center RAMS	Moscow		Russian Federation
29	Samara Regional Clinical Hospital	Samara		Russian Federation	443095
30	St. Petersburg Pavlov State Medical University	St. Petersburg		Russian Federation
31	Universitatsspital Zurich Dermatologische Klinik	Zurich		Switzerland
32	St. John's Institute of Dermatology	London		United Kingdom
33	City Hospital	Nottingham		United Kingdom
34	Southampton General Hospital	Southampton		United Kingdom