Infliximab in Treating Patients With Myelodysplastic Syndrome
RATIONALE: Monoclonal antibodies, such as infliximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to study the effectiveness of infliximab in treating patients who have myelodysplastic syndrome.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia|
- Best response as measured by Cheson response criteria [ Designated as safety issue: No ]
- Duration of highest grade toxicity as assessed by CTCAE v3.0 after response [ Designated as safety issue: Yes ]
|Study Start Date:||October 2003|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
- Determine the therapeutic activity of 2 different doses of infliximab on peripheral blood cell count and peripheral and bone marrow blast cell count in patients with low- or intermediate-risk myelodysplastic syndromes.
- Determine the subjective and objective toxicity of these regimens in these patients.
- Determine the response rates (complete and partial response and hematological improvement) in patients treated with these regimens.
- Determine the duration of response in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to cytogenetics (good vs intermediate vs unknown due to failure), overall International Prognostic Scoring System score (low  vs intermediate 1 [0.5-1.0] vs intermediate 2 [1.5-2.0]), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive infliximab IV on days 1, 15, 43, 71, 99, 127, 155, and 183 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive a higher dose of infliximab as in arm I. Patients achieving response (complete or partial response or hematological improvement) continue therapy beyond day 183 in the absence of disease progression.
Patients are followed at 2 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 2 years.
|Brugge, Belgium, 8000|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Hopital Universitaire Erasme|
|Brussels, Belgium, 1070|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|H. Hartziekenhuis - Roeselaere.|
|Roeselare, Belgium, 8800|
|Centre Hospitalier Peltzer-La Tourelle|
|Verviers, Belgium, B-4800|
|University Hospital - Olomouc|
|Olomouc, Czech Republic, 775 20|
|Institute of Hematology and Blood Transfusion|
|Prague, Czech Republic, 128 20|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Ruprecht - Karls - Universitaet Heidelberg|
|Heidelberg, Germany, D-69117|
|Stuttgart, Germany, 70199|
|Southwest German Cancer Center at Eberhard-Karls-University|
|Tuebingen, Germany, D-72076|
|Ospedale San Salvatore|
|Pesaro, Italy, I-61100|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1007 MB|
|Den Haag, Netherlands, 2597AX|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Universitair Medisch Centrum St. Radboud - Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Study Chair:||Heinz Zwierzina, MD||Medical University Innsbruck|