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

Mycosis Fungoides Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050999
• Other study ID #: 93-04-11
• Status: Completed
• Phase: Phase 4
• First received: December 31, 2002
• Last updated: February 29, 2008
• Start date: June 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 compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

Other known NCT identifiers

• NCT00002683

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, 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	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
Germany	Sektion Dermatologische Onkologie	Tubingen
Netherlands	LUMC, Department of Dermatology	Leiden
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,  Netherlands,  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