Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
This study has been completed.
Sponsor:
Eisai Inc.
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00051012
First received: December 31, 2002
Last updated: February 29, 2008
Last verified: February 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma, T-Cell, Cutaneous Mycosis Fungoides Sezary Syndrome |
Drug: ONTAK |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Eisai Inc.:
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
| Estimated Enrollment: | 86 |
| Study Start Date: | September 1995 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051012
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Hide Study LocationsLocations
| United States, Texas | |
| University of Texas, M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Australia, New South Wales | |
| Level 4 Department of Haematology Royal North Shore Hospital | |
| St. Leonard's, New South Wales, Australia, 2065 | |
| Westmead Hospital, Department of Haematology | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Mater Misericordiae Adult Hospital | |
| South Brisbane, Queensland, Australia, 4101 | |
| Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Institute | |
| Melbourne, Victoria, Australia, 3002 | |
| Austria | |
| LKH Universitatsklinikum Graz | |
| Graz, Austria, A-8036 | |
| Allgemeines Krankenhaus der Stadt Wien | |
| Vienna, Austria, A-1090 | |
| Canada, Alberta | |
| Cross Cancer Centre | |
| Edmonton, Alberta, Canada | |
| Canada, Ontario | |
| Hamilton Regional Cancer Center | |
| Hamilton, Ontario, Canada | |
| Canada, Quebec | |
| Jewish General Hospital | |
| Montreal, Quebec, Canada | |
| Germany | |
| Universitatsklinikum Charite | |
| Berlin, Germany | |
| University of Erlangen | |
| Erlangen, Germany, 91052 | |
| Universitatsklinikum Essen | |
| Essen, Germany, 45122 | |
| J.W. Goethe University Frankfurt | |
| Frankfurt, Germany, 60590 | |
| Universitatskrankenhaus Eppendorf | |
| Hamburg, Germany, 20246 | |
| Universitatsklinikum Mannheim | |
| Mannheim, Germany, 68135 | |
| Universitatsklinikum Munster | |
| Munster, Germany, D-48149 | |
| Poland | |
| Medical Academy in Gdansk, Dept. of Hematology | |
| Gdansk, Poland, 80-952 | |
| Regional Oncological Center, Dept. of Chemotherapy | |
| Lodz, Poland, 93-509 | |
| Klinika Hematoonkologii Akademii Medycznej w Lublinie | |
| Lublin, Poland, 20-950 | |
| Oddzial Chorob Wewnetrznych i Hematologii | |
| Poznan, Poland, 61-833 | |
| Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie | |
| Warsaw, Poland, 02-781 | |
| The Medical University of Warsaw, Central Clinical Hospital | |
| Warsaw, Poland, 02-097 | |
| Russian Federation | |
| Burdenko Main Military Clinical Hospital | |
| Moscow, Russian Federation | |
| Haematology Research Center RAMS | |
| Moscow, Russian Federation | |
| Central Research Institute of Skin and Venereal Diseases | |
| Moscow, Russian Federation | |
| Blokhin Russian Cancer Research Center, RAMS | |
| Moscow, Russian Federation | |
| Samara Regional Clinical Hospital | |
| Samara, Russian Federation, 443095 | |
| St. Petersburg Pavlov State Medical University | |
| St. Petersburg, Russian Federation | |
| Switzerland | |
| Universitatsspital Zurich Dermatologische Klinik | |
| Zurich, Switzerland | |
| United Kingdom | |
| St. John's Institute of Dermatology | |
| London, United Kingdom | |
| City Hospital | |
| Nottingham, United Kingdom | |
| Southampton General Hospital | |
| Southampton, United Kingdom | |
Sponsors and Collaborators
Eisai Inc.
Investigators
| Study Director: | Elyane Lombardy, M.D. | Ligand Pharmaceuticals |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00051012 History of Changes |
| Obsolete Identifiers: | NCT00005620 |
| Other Study ID Numbers: | 93-04-14 |
| Study First Received: | December 31, 2002 |
| Last Updated: | February 29, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Denileukin diftitox Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013