Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome

Phase 2

Withdrawn

• Conditions: Myelodysplastic Syndromes

• Registration Number: NCT00003984
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-05-24
• Study First Posted: 2004-05-25
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (27)

Western General Hospital; 🇬🇧 Edinburgh, Scotland, United Kingdom

Ninewells Hospital and Medical School; 🇬🇧 Dundee, Scotland, United Kingdom

Academisch Ziekenhuis der Vrije Universiteit; 🇳🇱 Amsterdam, Netherlands

Newcastle General Hospital; 🇬🇧 Newcastle Upon Tyne, England, United Kingdom

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Kantonsspital - Saint Gallen; 🇨🇭 Saint Gallen, Switzerland

C.R.C. Beatson Laboratories; 🇬🇧 Glasgow, Scotland, United Kingdom

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Ludwig Institute for Cancer Research-Brussels Branch; 🇧🇪 Brussels, 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

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Klinikum Nurnberg; 🇩🇪 Nuremberg (Nurnberg), Germany

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Inselspital, Bern; 🇨🇭 Bern, Switzerland

University Hospital; 🇨🇭 Basel, Switzerland