Study of EB10 in Patients With Leukemia

Inclusion Criteria:

1. The patient has acute myeloid leukemia in the bone marrow or blood that has relapsed with or without a prior complete remission
2. The patient is not regarded to be a candidate for a potentially curative, higher priority treatment for acute myeloid leukemia
3. The patient has resolution of all clinically significant toxic effects of any prior antitumor therapy and any other study-specific clinical or laboratory parameter specified in the entry criteria
4. The patient has not had major surgery, an open biopsy, a significant injury, and/or prior antitumor therapy (except antileukemia therapy) within 21 days prior to the first infusion of IMC-EB10
5. The patient has a performance status of 0, 1, or 2 at study entry.
6. The patient is age 18 years or older
7. The patient has a life expectancy of > 3 months
8. The patient has adequate liver and kidney function, as defined in the entry criteria
9. The patient is using an effective contraception (per the institutional standard), if procreative potential exists
10. The patient is able to give written informed consent
11. The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans

Exclusion Criteria:

1. The patient has had prior allogenic or autologous stem cell transplant within < 3 months of the first infusion of IMC-EB10
2. The patient has had an organ transplant (nonhematologic) within 3 years of study entry
3. The patient has active central nervous system leukemia
4. The patient has extramedullary disease without peripheral/and or bone marrow involvement
5. The patient is disease-free from a previous or concurrent malignancy for a period ≤ 1 year. A patient who has basal cell carcinoma or carcinoma in situ of the cervix will not be excluded from the study
6. The patient is currently receiving antileukemia therapy. Concurrent treatment with hydroxyurea is permitted
7. The patient has uncontrolled intercurrent illness as specified in the study entry criteria
8. The patient is receiving chronic steroid or other immunosuppressive medications. Occasional use of steroid-containing medications, eg, for asthma exacerbation or for skin lesions, is permitted
9. The patient is receiving full-dose heparin (including low molecular weight heparin) or warfarin. (The patient is permitted to use low-dose warfarin to maintain patency of preexisting, permanent, indwelling I.V. catheters.)
10. The patient is pregnant (confirmed by urine or serum pregnancy test) or breast feeding
11. The patient has received treatment with monoclonal antibodies within 6 weeks prior to first infusion of IMC-EB10
12. The patient has a history of clinically significant allergic reactions to monoclonal antibodies or other therapeutic proteins