Cytarabine and UCN-01 in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Completed · Phase 1

Conditions studied: Leukemia, Myelodysplastic Syndromes

In brief

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. UCN-01 may make cancer cells more sensitive to cytarabine. PURPOSE: Phase I trial to study the effectiveness of cytarabine and UCN-01 in treating patients who have refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome.

Key facts

Study ID

NCT00004263

Run by

M.D. Anderson Cancer Center

People needed

16

Starts

1999-12-01

Expected to finish

2007-01-01

Last updated by the study team

2012-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Patients with refractory or relapsed acute myelogenous leukemia, or myelodysplastic syndromes (RAEB or RAEB-T).
• 2. Performance status of =< 2
• 3. Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol for each participating institution.
• 4. Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
• 5. Bilirubin and creatinine (or creatinine clearance) should be within institutional normal limits.
• 6. Patients must have relapsed or failed to respond after high-dose ara-C-based (>=1g/m2/day x 3 days) chemotherapy.
• 7. Corrected DLCO >50%.
• 8. Patients with >=3 cardiac risk factors (smoking, hypertension, family history of coronary artery disease, diabetes mellitus, hypercholesterolemia) should have a nuclear medicine stress test.

You may not qualify if…

• 1. The anti-proliferative activity of the experimental drug may be harmful to the developing fetus or nursing infant. Therefore, pregnant and nursing females will be excluded. Patients of childbearing potential should practice effective methods of contraception.
• 2. Patients who are eligible for allogeneic marrow transplant and who have a donor will be offered transplant.
• 3. Patients with existing pulmonary diseases, history of coronary artery disease or who have received radiotherapy to the mediastinum.

Where it is running

• Arthur G. James Cancer Hospital - Ohio State University — Columbus, Ohio, United States
• University of Texas - MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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