Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary myelodysplastic syndrome (MDS) with greater than 10% bone marrow blasts Refractory anemia with excess blasts (RAEB) OR RAEB in transformation No chronic myelomonocytic leukemia No secondary MDS after prior chemotherapy except if treatment was for acute myeloid leukemia No allogeneic bone marrow transplantation planned PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin no greater than 10 g/dL OR transfusion requirement of at least 3 packs of RBCs per month OR Platelet count less than 50,000/mm3 OR Absolute neutrophil count less than 1,000/mm3 No disseminated intravascular coagulation defined as fibrinogen less than 100 mg/dL AND prolonged PT, PTT, or thrombin time AND platelet count less than 25,000/mm3 without transfusion Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 4 times upper limit of normal (ULN) (unless due to underlying disease or Gilbert's syndrome) SGPT and SGOT no greater than 4 times ULN (unless due to underlying disease or Gilbert's syndrome) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension No congestive heart failure, cardiac arrhythmia, or angina pectoris No history of myocardial infarction within the past 6 months No other significant cardiovascular disease LVEF within normal range by MUGA or echocardiogram No active ischemia Pulmonary: No pulmonary dysfunction Other: No central or peripheral neuropathy No uncontrolled or unstable diabetes No other significant organ system dysfunction HIV negative No prior malignancy except basal cell carcinoma or carcinoma in situ of the uterus No active, uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 2 months since prior biologic therapy (e.g., hematopoietic growth factors or biological response modifiers) Chemotherapy: See Disease Characteristics At least 2 months since prior chemotherapy Endocrine therapy: At least 2 months since prior endocrine therapy Radiotherapy: At least 2 months since prior radiotherapy Concurrent radiotherapy allowed Surgery: At least 2 months since prior surgery Other: No other concurrent investigational drugs
Sites / Locations
- Innsbruck Universitaetsklinik
- Kaiser Franz Josef Hospital
- Institut Jules Bordet
- Ludwig Institute for Cancer Research-Brussels Branch
- Universitair Ziekenhuis Antwerpen
- U.Z. Gasthuisberg
- Herlev Hospital - University Hospital of Copenhagen
- Centre Jean Perrin
- Centre Leon Berard
- CRLCC Nantes - Atlantique
- Institut Claudius Regaud
- Institut Gustave Roussy
- Universitaetsklinik und Strahlenklinik - Essen
- Klinikum Nurnberg
- Antoni van Leeuwenhoekhuis
- Academisch Ziekenhuis der Vrije Universiteit
- Academisch Ziekenhuis Groningen
- University Medical Center Nijmegen
- Rotterdam Cancer Institute
- Norwegian Radium Hospital
- University Hospital
- Inselspital, Bern
- Kantonsspital - Saint Gallen
- Newcastle General Hospital
- Ninewells Hospital and Medical School
- Western General Hospital
- C.R.C. Beatson Laboratories