Oxaliplatin, Fludarabine, and Cytarabine in Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS)

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find the highest tolerable dose of oxaliplatin combined with fludarabine plus cytarabine that can be given to patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS). Once the highest tolerable dose of oxaliplatin in this drug combination is found, the next goal of the study will be to learn the safety and the ability of the drug combination to control the disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Sanofi
• Treatments: Cytarabine; Fludarabine; Fludarabine phosphate; Oxaliplatin; Vidarabine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome.

• Performance status 0-2 (Zubrod scale).

• Serum creatinine equal or less than 1.3 mg/dL or creatinine clearance > 40 mL/min.

• Bilirubinglutamic pyruvic transaminase (SGPT)the reference lab unless due to leukemia or congenital hemolytic disorder (for bilirubin).

• Written informed consent.

Exclusion Criteria:

• No untreated or uncontrolled life-threatening infection.

• No oxaliplatin, fludarabine, or cytarabine intolerance.

• No pregnancy or lactation. Female patients of childbearing potential (including those < 1 year post-menopausal) and male patients must agree to use contraception.

• No chemotherapy or radiation therapy within 4 weeks of study entry. Hydroxyurea is allowed prior to starting therapy in the setting of rapidly proliferating disease.

• No other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or to interfere with the interpretation of the results.