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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome  Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
For Condition: Previously Treated Myelodysplastic Syndrome,refractory anemia with excess blasts,secondary myelodysplastic syndrome,refractory anemia with excess blasts in transformation,de novo myelodysplastic syndrome
Status: No longer recruiting
Sponsor(s): EORTC Biological Therapeutics Development Study Group ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HeinzZwierzina, Study Chair, EORTC Biological Therapeutics Development Study Group
Institut Claudius Regaud
Toulouse, , 31052
France
Institut Jules Bordet
Brussels, , 1000
Belgium
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
University Hospital
Basel, , CH-4031
Switzerland
Innsbruck Universitaetsklinik
Innsbruck, , A-6020
Austria
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Inselspital, Bern
Bern, , CH-3010
Switzerland
Herlev Hospital - University Hospital of Copenhagen
Herlev, , DK-2730
Denmark
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Ludwig Institute for Cancer Research-Brussels Branch
Brussels, , B-1200
Belgium
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
Centre Leon Berard
Lyon, , 69373
France
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , 1117 MB
Netherlands
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
Institut Gustave Roussy
Villejuif, , F-94805
France
Klinikum Nurnberg
Nuremberg (Nurnberg), , D-90419
Germany
Kantonsspital - Saint Gallen
Saint Gallen, , CH-9007
Switzerland
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Additional Information:
Study ID Numbers: CDR0000067188; EORTC-13981
Study Start Date: February 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003984
Other Previously Treated Myelodysplastic Syndrome Studies:
1. Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
2. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
3. Gemtuzumab in Treating Patients With Myelodysplastic Syndrome
4. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
5. Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
Related Studies:
Other Previously Treated Myelodysplastic Syndrome Clinical Trials
Other Clinical Trials
Other Nijmegen Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
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