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Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003984
  Purpose

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.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: lintuzumab
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Lintuzumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Trial With a Recombinant Humanized Anti-CD33 Monoclonal Antibody (HuM195) in Patients With High Risk Primary Myelodysplastic Syndromes

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   25
Study Start Date:   February 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003984

Locations
Austria
Innsbruck Universitaetsklinik    
      Innsbruck, Austria, A-6020
Kaiser Franz Josef Hospital    
      Vienna, Austria, A-1100
Belgium
Institut Jules Bordet    
      Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen    
      Edegem, Belgium, B-2650
U.Z. Gasthuisberg    
      Leuven, Belgium, B-3000
Ludwig Institute for Cancer Research-Brussels Branch    
      Brussels, Belgium, B-1200
Denmark
Herlev Hospital - University Hospital of Copenhagen    
      Herlev, Denmark, DK-2730
France
Centre Jean Perrin    
      Clermont-Ferrand, France, 63011
Centre Leon Berard    
      Lyon, France, 69373
CRLCC Nantes - Atlantique    
      Nantes-Saint Herblain, France, 44805
Institut Claudius Regaud    
      Toulouse, France, 31052
Institut Gustave Roussy    
      Villejuif, France, F-94805
Germany
Klinikum Nurnberg    
      Nuremberg (Nurnberg), Germany, D-90419
Universitaetsklinik und Strahlenklinik - Essen    
      Essen, Germany, D-45122
Netherlands
Academisch Ziekenhuis der Vrije Universiteit    
      Amsterdam, Netherlands, 1117 MB
Academisch Ziekenhuis Groningen    
      Groningen, Netherlands, 9713 EZ
Antoni van Leeuwenhoekhuis    
      Amsterdam, Netherlands, 1066 CX
Rotterdam Cancer Institute    
      Rotterdam, Netherlands, 3075 EA
University Medical Center Nijmegen    
      Nijmegen, Netherlands, NL-6252 HB
Norway
Norwegian Radium Hospital    
      Oslo, Norway, N-0310
Switzerland
Inselspital, Bern    
      Bern, Switzerland, CH-3010
Kantonsspital - Saint Gallen    
      Saint Gallen, Switzerland, CH-9007
University Hospital    
      Basel, Switzerland, CH-4031
United Kingdom, England
Newcastle General Hospital    
      Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
United Kingdom, Scotland
Western General Hospital    
      Edinburgh, Scotland, United Kingdom, EH4 9NQ
Ninewells Hospital and Medical School    
      Dundee, Scotland, United Kingdom, DD1 9SY
C.R.C. Beatson Laboratories    
      Glasgow, Scotland, United Kingdom, G61 1BD

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Heinz Zwierzina, MD     Innsbruck Universitaetsklinik    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067188, EORTC-13981
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003984
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory anemia with excess blasts  
refractory anemia with excess blasts in transformation  
de novo myelodysplastic syndromes  
previously treated myelodysplastic syndromes  
secondary myelodysplastic syndromes  

Study placed in the following topic categories:
Myelodysplastic syndromes
Precancerous Conditions
Hematologic Diseases
Refractory anemia
Myelodysplastic Syndromes
Myelodysplasia
Anemia
Antibodies, Monoclonal
Antibodies
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Immunologic Factors
Syndrome
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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