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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00074074 |
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.
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndromes |
Biological: infliximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia |
Estimated Enrollment: | 80 |
Study Start Date: | October 2003 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis (within the past month) of low- or intermediate-risk myelodysplastic syndromes (MDS) meeting all of the following criteria:
Meets at least 1 of the following hematopoietic criteria:
No poor cytogenetics (complex abnormalities or involvement of chromosome 7)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No prior or concurrent active or latent tuberculosis (TB)
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
No prior solid organ transplantation
Other
No concurrent therapeutic-dose nonsteroidal anti-inflammatory drugs (NSAIDs)
Belgium | |
AZ Sint-Jan | |
Brugge, Belgium, 8000 | |
Centre Hospitalier Peltzer-La Tourelle | |
Verviers, Belgium, B-4800 | |
H. Hartziekenhuis - Roeselaere. | |
Roeselare, Belgium, 8800 | |
Hopital Universitaire Erasme | |
Brussels, Belgium, 1070 | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
Czech Republic | |
Institute of Hematology and Blood Transfusion | |
Prague, Czech Republic, 128 20 | |
University Hospital - Olomouc | |
Olomouc, Czech Republic, 775 20 | |
France | |
Centre Antoine Lacassagne | |
Nice, France, 06189 | |
Hotel Dieu de Paris | |
Paris, France, 75181 | |
Germany | |
Marienhospital Stuttgart | |
Stuttgart, Germany, 70199 | |
Ruprecht - Karls - Universitaet Heidelberg | |
Heidelberg, Germany, D-69117 | |
Southwest German Cancer Center at Eberhard-Karls-University | |
Tuebingen, Germany, D-72076 | |
Italy | |
Ospedale San Salvatore | |
Pesaro, Italy, I-61100 | |
Netherlands | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC | |
Universitair Medisch Centrum St. Radboud - Nijmegen | |
Nijmegen, Netherlands, NL-6500 HB | |
Vrije Universiteit Medisch Centrum | |
Amsterdam, Netherlands, 1007 MB | |
Ziekenhuis Bronovo | |
Den Haag, Netherlands, 2597AX |
Investigator: | Heinz Zwierzina, MD | Innsbruck Universitaetsklinik |
Investigator: | Claudio Denzlinger, MD | Marienhospital Stuttgart |
Study ID Numbers: | CDR0000341685, EORTC-06023 |
Study First Received: | December 10, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00074074 History of Changes |
Health Authority: | United States: Federal Government |
refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia |
de novo myelodysplastic syndromes secondary myelodysplastic syndromes previously treated myelodysplastic syndromes |
Anti-Inflammatory Agents Precancerous Conditions Hematologic Diseases Infliximab Myelodysplastic Syndromes Anemia Refractory Anemia |
Leukemia Preleukemia Anemia, Refractory Neoplasm Metastasis Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Antirheumatic Agents |
Anti-Inflammatory Agents Disease Precancerous Conditions Hematologic Diseases Infliximab Myelodysplastic Syndromes Gastrointestinal Agents Pharmacologic Actions |
Preleukemia Neoplasms Pathologic Processes Syndrome Therapeutic Uses Antirheumatic Agents Bone Marrow Diseases Dermatologic Agents |