This phase I trial studies the side effects and best dose of anti-PR1/HLA-A2 monoclonal antibody Hu8F4 (Hu8F4) in treating patients with malignancies related to the blood (hematologic). Monoclonal antibodies, such as Hu8F4, may interfere with the ability of cancer cells to grow and spread.
PRIMARY OBJECTIVES: I. To determine the dose limiting toxicity (DLT) and minimum safe and biologically-effective dose of Hu8F4 when administered intravenously in patients with leukemia or myelodysplastic syndrome (MDS). II. To determine the pharmacokinetics (PK) of Hu8F4 following study drug administration. SECONDARY OBJECTIVES: I. To observe the anti-leukemia effects of Hu8F4 in patients with leukemias and MDS. II. To measure the overall survival, disease-free survival and event-free survival of patients with leukemias or MDS treated with Hu8F4. OUTLINE: This is a dose-escalation study. Patients receive anti-PR1/HLA-A2 monoclonal antibody Hu8F4 intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Given IV
Correlative studies
Correlative studies
Augusta University
Augusta, Georgia, United States
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, United States
M D Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Minimum safety data
Safety data will be summarized using frequency and percentage for all patients.
Time frame: 4 weeks
Biologically-effective dose
Safety data will be summarized using frequency and percentage for all patients.
Time frame: 4 weeks
Overall survival
Estimated using the Kaplan-Meier methods.
Time frame: Up to 4 years
Disease-free survival
Estimated using the Kaplan-Meier methods.
Time frame: Up to 4 years
Event-free survival
Estimated using the Kaplan-Meier methods.
Time frame: Up to 4 years
Duration of complete remission
Complete remission rates will be estimated along with 95% credible intervals. Estimated using the Kaplan-Meier methods.
Time frame: Up to 4 years
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