Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
Phase II Trial With a Recombinant Humanized Anti-CD33 Monoclonal Antibody (HuM195) in Patients With High Risk Primary Myelodysplastic Syndromes
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Brussels, Belgia, 1000
- Institut Jules Bordet
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Brussels, Belgia, B-1200
- Ludwig Institute for Cancer Research-Brussels Branch
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Edegem, Belgia, B-2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgia, B-3000
- U.Z. Gasthuisberg
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Herlev, Danmark, DK-2730
- Herlev Hospital - University Hospital of Copenhagen
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Clermont-Ferrand, Frankrike, 63011
- Centre Jean Perrin
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Lyon, Frankrike, 69373
- Centre Léon Bérard
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Nantes-Saint Herblain, Frankrike, 44805
- CRLCC Nantes - Atlantique
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Toulouse, Frankrike, 31052
- Institut Claudius Regaud
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Villejuif, Frankrike, F-94805
- Institut Gustave Roussy
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Amsterdam, Nederland, 1066 CX
- Antoni van Leeuwenhoekhuis
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Amsterdam, Nederland, 1117 MB
- Academisch Ziekenhuis der Vrije Universiteit
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Groningen, Nederland, 9713 EZ
- Academisch Ziekenhuis Groningen
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Nijmegen, Nederland, NL-6252 HB
- University Medical Center Nijmegen
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Rotterdam, Nederland, 3075 EA
- Rotterdam Cancer Institute
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Oslo, Norge, N-0310
- Norwegian Radium Hospital
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England
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Newcastle Upon Tyne, England, Storbritannia, NE4 6BE
- Newcastle General Hospital
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Scotland
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Dundee, Scotland, Storbritannia, DD1 9SY
- Ninewells Hospital and Medical School
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Edinburgh, Scotland, Storbritannia, EH4 9NQ
- Western General Hospital
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Glasgow, Scotland, Storbritannia, G61 1BD
- C.R.C. Beatson Laboratories
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Basel, Sveits, CH-4031
- University Hospital
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Bern, Sveits, CH-3010
- Inselspital, Bern
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Saint Gallen, Sveits, CH-9007
- Kantonsspital - Saint Gallen
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Essen, Tyskland, D-45122
- Universitaetsklinik und Strahlenklinik - Essen
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Nuremberg (Nurnberg), Tyskland, D-90419
- Klinikum Nürnberg
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Innsbruck, Østerrike, A-6020
- Innsbruck Universitaetsklinik
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Vienna, Østerrike, A-1100
- Kaiser Franz Josef Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Heinz Zwierzina, MD, Medical University Innsbruck
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EORTC-13981
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