Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed/Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

September 30, 1998

Primary Completion Date

April 30, 2002

Study Completion Date

March 31, 2003

Conditions
LeukemiaMyelodysplastic Syndromes
Interventions
DRUG

carboplatin

Patients receive carboplatin IV continuously over 30 minutes on days 1-5. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy.

DRUG

fludarabine phosphate

Patients receive fludarabine IV over 30 minutes on days 1-5. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy.

DRUG

topotecan hydrochloride

This is a dose escalation study of topotecan. Patients receive topotecan IV continuously on days 6-8. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy.

Trial Locations (1)

44106-5065

Ireland Cancer Center at University Hospitals Case Medical Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT00005593 - Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed/Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome | Biotech Hunter | Biotech Hunter