Clinical Trial Detail

The purpose of this study is to determine the safety, side effects (good or bad), and how much radiation can be given using treatment with an experimental drug called Iodine-131-radiolabeled BC8 monoclonal antibody (or I-131-BC8), in patients with acute myelogenous leukemia (AML) or high risk myelodysplastic syndrome (MDS). The treatment with the experimental drug will be followed by a chemotherapy drug called fludarabine, a low dose of total body radiation, and a donor stem cell transplant.

Some of the treatment will be given in the outpatient clinic at the Seattle Cancer Care Alliance (SCCA). Treatment with the experimental drug, I-131-BC8, will take place at the University of Washington Medical Center. The participant will receive a test dose of I-131-BC8 using a small amount of radiation, followed by imaging tests that will take place over the next few days.

About 10 days later, the participant will receive a treatment dose of I-131-BC8 using a much larger dose of radiation. The participant will stay alone in a radiation isolation room at the hospital for about 5 to 10 days after receiving this dose. After the isolation period, participants will receive fludarabine and low dose radiation followed by a stem cell transplant. Participants will also receive the drugs cyclosporine and mycophenolate mofetil starting before or on the day of the transplant and continue taking these drugs for a few weeks or months after transplant.

Participants will be in the study for at least 3 ½ months, but possibly longer. After this treatment period, participants will return to the care of their primary oncologist.

In order to look at the long-term effects of the study, participants will be asked to allow Fred Hutchinson Cancer Research Center to continue to get information from the referring physician and send questionnaires about participants’ health after the study. It is strongly recommended that thyroid function tests be performed one or more times a year following treatment on this study.

- 1) Diagnosed with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).

- AML patients must have AML that has either:

- a) come back after first remission, or

- b) did not respond to initial treatment, or

- c) evolved from myelodysplastic or myeloproliferative syndrome.

- MDS patients must have one of the following:

- a) refractory anemia with excess blasts (RAEB),

- b) RAEB in transformation (RAEBT),

- c) refractory cytopenia with multilineage dysplasia (RCMD),

- d) RCMD with ringed sideroblasts (RCMD-RS), or

- e) chronic myelomonocytic leukemia (CMML).

- 2) Must be between 16 and 50 years of age.

- 3) Must have normal liver and kidney function (must undergo a 24-hour urine collection to test kidneys).

- 4) Must be physically able to meet study requirements.

- 5) Must not have active infection.

- 6) Must have a healthy, matched, related or unrelated donor according to study guidelines.

Other eligibility criteria may apply.

- 1) Already received maximum radiation to any organ.

- 2) Severe heart problems requiring medication, or symptoms of coronary artery disease.

- 3) HIV positive.

- 4) Medical or other condition that may prevent the patient from finishing the study.

- 5) Already undergone bone marrow or stem cell transplant.

Other exclusion criteria may apply.