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Brief Title: Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
Official Title: Phase II Trial With a Recombinant Humanized Anti-CD33 Monoclonal Antibody (HuM195) in Patients With High Risk Primary Myelodysplastic Syndromes
Study ID: NCT00003984
Brief Summary: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have primary myelodysplastic syndrome.
Detailed Description: OBJECTIVES: I. Assess the therapeutic activity of monoclonal antibody HuG1-M195 on peripheral blood and bone marrow blast cell count, blood leukocyte, reticulocyte, and platelet counts, and hemoglobin levels in patients with myelodysplastic syndrome with refractory anemia with excess blasts (RAEB) (greater than 10% bone marrow myeloblasts) or RAEB in transformation. II. Assess the efficacy of this drug in terms of duration of response in these patients. III. Evaluate the toxicity of this drug in these patients. OUTLINE: Patients receive monoclonal antibody HuG1-M195 IV over 4 hours on days 1-4. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with progressive disease after 2 courses are removed from study. Patients with stable disease receive no further treatment after 4 courses. Patients with complete or partial response receive treatment for 4 additional courses. Patients are followed at 11 and 39 days after end of course 4, monthly for 4 months, then every 3 months thereafter for 1 year from study entry. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Innsbruck Universitaetsklinik, Innsbruck, , Austria
Kaiser Franz Josef Hospital, Vienna, , Austria
Institut Jules Bordet, Brussels, , Belgium
Ludwig Institute for Cancer Research-Brussels Branch, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Herlev Hospital - University Hospital of Copenhagen, Herlev, , Denmark
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Leon Berard, Lyon, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Institut Claudius Regaud, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Universitaetsklinik und Strahlenklinik - Essen, Essen, , Germany
Klinikum Nurnberg, Nuremberg (Nurnberg), , Germany
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Rotterdam Cancer Institute, Rotterdam, , Netherlands
Norwegian Radium Hospital, Oslo, , Norway
University Hospital, Basel, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Kantonsspital - Saint Gallen, Saint Gallen, , Switzerland
Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
C.R.C. Beatson Laboratories, Glasgow, Scotland, United Kingdom
Name: Heinz Zwierzina, MD
Affiliation: Medical University Innsbruck
Role: STUDY_CHAIR