Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00003984

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes	Biological: lintuzumab	Phase 2

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Primary Purpose:

Treatment

Official Title:

Phase II Trial With a Recombinant Humanized Anti-CD33 Monoclonal Antibody (HuM195) in Patients With High Risk Primary Myelodysplastic Syndromes

Study Start Date :

Feb 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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