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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00051012
Other study ID # 93-04-14
Secondary ID
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


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
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