Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
About this trial
This is an interventional treatment trial for Lymphoma, T-Cell, Cutaneous
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.
Sites / Locations
- University of Texas, M.D. Anderson Cancer Center
- Level 4 Department of Haematology Royal North Shore Hospital
- Westmead Hospital, Department of Haematology
- Mater Misericordiae Adult Hospital
- Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital
- Peter MacCallum Cancer Institute
- LKH Universitatsklinikum Graz
- Allgemeines Krankenhaus der Stadt Wien
- Cross Cancer Centre
- Hamilton Regional Cancer Center
- Jewish General Hospital
- Universitatsklinikum Charite
- University of Erlangen
- Universitatsklinikum Essen
- J.W. Goethe University Frankfurt
- Universitatskrankenhaus Eppendorf
- Universitatsklinikum Mannheim
- Universitatsklinikum Munster
- Medical Academy in Gdansk, Dept. of Hematology
- Regional Oncological Center, Dept. of Chemotherapy
- Klinika Hematoonkologii Akademii Medycznej w Lublinie
- Oddzial Chorob Wewnetrznych i Hematologii
- The Medical University of Warsaw, Central Clinical Hospital
- Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
- Blokhin Russian Cancer Research Center, RAMS
- Burdenko Main Military Clinical Hospital
- Central Research Institute of Skin and Venereal Diseases
- Haematology Research Center RAMS
- Samara Regional Clinical Hospital
- St. Petersburg Pavlov State Medical University
- Universitatsspital Zurich Dermatologische Klinik
- St. John's Institute of Dermatology
- City Hospital
- Southampton General Hospital