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


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Heinz Zwierzina, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University Innsbruck

Authority:

United States: Federal Government

Study ID:

EORTC-13981

NCT ID:

NCT00003984

Start Date:

February 1999

Completion Date:

Related Keywords:

  • Myelodysplastic Syndromes
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • Myelodysplastic Syndromes
  • Preleukemia

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