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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00074074 |
Purpose
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.
Eligibility| 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)
Contacts and Locations| 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 |
More Information
| 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 |