Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of azacitidine when given together with arsenic trioxide and to see how well they work in treating patients with myelodysplastic syndromes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Celgene Corporation; CTI BioPharma; National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Azacitidine

Criteria

Inclusion Criteria:

• Confirmed diagnosis of MDS by standard criteria. Patients within each of the FAB diagnostic groups of RA, RARS, RAEB, RAEBt, and CMML are eligible. For patients with lower-risk MDS only: documented red blood cell dependence, defined as the inability to maintain a hematocrit of > 25% without transfusion support.

• Adequate marrow iron stores

• In patients with serum erythropoietin less than 200 IU/mL at screening, failure to have responded to a 2 to 3 month trial of recombinant erythropoietin

• Serum creatinine or serum bilirubin < 1.5 times the upper limit of normal; higher levels are acceptable if ALT levels < 2 x upper limits of normal

• Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine/treatment.

• Women of childbearing potential should be advised to avoid becoming pregnant and should be advised to not father a child while receiving treatment with azacitidine

• Age > 18 years

Exclusion Criteria:

• Treatment with growth factors within the 30 days before first treatment with ATO/Azacitidine, except that patients with serum erythropoietin < 200 IU/mL who failed to respond to a trial with EPO are not excluded regardless of the time since last EPO

• Treatment with cytotoxic or experimental agents within 30 days before first treatment with ATO/Azacitidine

• Absolute QT interval > 460 msec in the presence of adequate serum potassium and magnesium values

• Active serious infections that are not controlled by antibiotics

• Pregnant or lactating women

• Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests

• NYHA Class III or IV heart failure

• Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol