Clinical trial NCT00051012: Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Sezary Syndrome
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2003-01-03
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Rate of Response (ORR), defined as CR + CCR + PR
Secondary outcomes:
measure: Time-to-Treatment Failure
measure: Time-to-Progression
measure: Duration of Response
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas, M.D. Anderson Cancer Center
state: Texas
city: St. Leonard's
country: Australia
facility: Level 4 Department of Haematology Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital, Department of Haematology
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute
state: Victoria
city: Graz
country: Austria
facility: LKH Universitatsklinikum Graz
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Edmonton
country: Canada
facility: Cross Cancer Centre
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Regional Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Berlin
country: Germany
facility: Universitatsklinikum Charite
city: Erlangen
country: Germany
facility: University of Erlangen
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Frankfurt
country: Germany
facility: J.W. Goethe University Frankfurt
city: Hamburg
country: Germany
facility: Universitatskrankenhaus Eppendorf
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim
city: Munster
country: Germany
facility: Universitatsklinikum Munster
city: Gdansk
country: Poland
facility: Medical Academy in Gdansk, Dept. of Hematology
city: Lodz
country: Poland
facility: Regional Oncological Center, Dept. of Chemotherapy
city: Lublin
country: Poland
facility: Klinika Hematoonkologii Akademii Medycznej w Lublinie
city: Poznan
country: Poland
facility: Oddzial Chorob Wewnetrznych i Hematologii
city: Warsaw
country: Poland
facility: The Medical University of Warsaw, Central Clinical Hospital
city: Warsaw
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
city: Moscow
country: Russian Federation
facility: Blokhin Russian Cancer Research Center, RAMS
city: Moscow
country: Russian Federation
facility: Burdenko Main Military Clinical Hospital
city: Moscow
country: Russian Federation
facility: Central Research Institute of Skin and Venereal Diseases
city: Moscow
country: Russian Federation
facility: Haematology Research Center RAMS
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical University
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich Dermatologische Klinik
city: London
country: United Kingdom
facility: St. John's Institute of Dermatology
city: Nottingham
country: United Kingdom
facility: City Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Ligand Pharmaceuticals
name: Elyane Lombardy, M.D.
role: STUDY_DIRECTOR
References:
citation: Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. doi: 10.1016/j.clml.2013.02.020. Epub 2013 Jun 14.