Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
NCT ID: NCT00003984
Last Updated: 2012-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
1999-02-28
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have primary myelodysplastic syndrome.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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lintuzumab
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Heinz Zwierzina, MD
Role: STUDY_CHAIR
Medical University Innsbruck
Locations
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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
Sankt 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
Countries
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Other Identifiers
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EORTC-13981
Identifier Type: -
Identifier Source: secondary_id
EORTC-13981
Identifier Type: -
Identifier Source: org_study_id