Infliximab in Treating Patients With Myelodysplastic Syndrome
- Conditions
- Myelodysplastic Syndromes
- Registration Number
- NCT00074074
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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 \[0\] 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best response as measured by Cheson response criteria
- Secondary Outcome Measures
Name Time Method Duration of highest grade toxicity as assessed by CTCAE v3.0 after response
Trial Locations
- Locations (19)
Institute of Hematology and Blood Transfusion
🇨🇿Prague, Czech Republic
Ziekenhuis Bronovo
🇳🇱Den Haag, Netherlands
AZ Sint-Jan
🇧🇪Brugge, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
H. Hartziekenhuis - Roeselaere.
🇧🇪Roeselare, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Centre Hospitalier Peltzer-La Tourelle
🇧🇪Verviers, Belgium
University Hospital - Olomouc
🇨🇿Olomouc, Czech Republic
Centre Antoine Lacassagne
🇫🇷Nice, France
Hotel Dieu de Paris
🇫🇷Paris, France
Ruprecht - Karls - Universitaet Heidelberg
🇩🇪Heidelberg, Germany
Marienhospital Stuttgart
🇩🇪Stuttgart, Germany
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Ospedale San Salvatore
🇮🇹Pesaro, Italy
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands