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

Mycosis Fungoides Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051012
• Other study ID #: 93-04-14
• Status: Completed
• Phase: Phase 4
• First received: December 31, 2002
• Last updated: February 29, 2008
• Start date: September 1995
• Est. completion date: December 2006

Study information

• Verified date: February 2008
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00005620

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycosis Fungoides
• Sezary Syndrome

Intervention

Drug:
• ONTAK

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Institute	Melbourne	Victoria
Australia	Mater Misericordiae Adult Hospital	South Brisbane	Queensland
Australia	Level 4 Department of Haematology Royal North Shore Hospital	St. Leonard's	New South Wales
Australia	Westmead Hospital, Department of Haematology	Westmead	New South Wales
Australia	Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	LKH Universitatsklinikum Graz	Graz
Austria	Allgemeines Krankenhaus der Stadt Wien	Vienna
Canada	Cross Cancer Centre	Edmonton	Alberta
Canada	Hamilton Regional Cancer Center	Hamilton	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Germany	Universitatsklinikum Charite	Berlin
Germany	University of Erlangen	Erlangen
Germany	Universitatsklinikum Essen	Essen
Germany	J.W. Goethe University Frankfurt	Frankfurt
Germany	Universitatskrankenhaus Eppendorf	Hamburg
Germany	Universitatsklinikum Mannheim	Mannheim
Germany	Universitatsklinikum Munster	Munster
Poland	Medical Academy in Gdansk, Dept. of Hematology	Gdansk
Poland	Regional Oncological Center, Dept. of Chemotherapy	Lodz
Poland	Klinika Hematoonkologii Akademii Medycznej w Lublinie	Lublin
Poland	Oddzial Chorob Wewnetrznych i Hematologii	Poznan
Poland	Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie	Warsaw
Poland	The Medical University of Warsaw, Central Clinical Hospital	Warsaw
Russian Federation	Blokhin Russian Cancer Research Center, RAMS	Moscow
Russian Federation	Burdenko Main Military Clinical Hospital	Moscow
Russian Federation	Central Research Institute of Skin and Venereal Diseases	Moscow
Russian Federation	Haematology Research Center RAMS	Moscow
Russian Federation	Samara Regional Clinical Hospital	Samara
Russian Federation	St. Petersburg Pavlov State Medical University	St. Petersburg
Switzerland	Universitatsspital Zurich Dermatologische Klinik	Zurich
United Kingdom	St. John's Institute of Dermatology	London
United Kingdom	City Hospital	Nottingham
United Kingdom	Southampton General Hospital	Southampton
United States	University of Texas, M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Germany,  Poland,  Russian Federation,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Rate of Response (ORR), defined as CR + CCR + PR
Secondary	Time-to-Treatment Failure
Secondary	Time-to-Progression
Secondary	Duration of Response