Status:
TERMINATED
Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Duke University
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. G...
Detailed Description
OBJECTIVES: Primary * Determine the complete response (CR) rate (CR and incomplete blood count recovery (CRi)) of patients with acute myeloid leukemia in first relapse treated with gemcitabine hydro...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Bone marrow examination or peripheral blood analysis confirming active acute myeloid leukemia by WHO criteria
- No M3 acute myeloid leukemia
- Not a candidate for allogenic bone marrow transplantation
- Patient must be in first relapse after having received induction chemotherapy
- Received 1 or 2 courses with remission lasting at least 1 month
- Patients with chloromas or leukemia cutis are eligible
- No evidence of leptomeningeal involvement
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Liver enzymes (total bilirubin, aspartate aminotransferase (AST) and ALT) ≤ 2.5 times the upper limits of normal
- Liver enzymes ≥ 2.5 are acceptable if physician documents that it is secondary to the disease
- Serum creatinine ≤ 3 mg/dL
- No poorly controlled medical conditions that would seriously complicate compliance with this study
- No other active primary malignancy other than carcinoma in situ of the cervix or basal cell carcinoma of the skin
- No New York Heart Association grade III or IV cardiac problems, defined as congestive heart failure or myocardial infarction within 6 months prior to start of study
- Pregnant or nursing women are ineligible
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No documented history of human immunodeficiency virus (HIV) infection
- No history of chronic liver disease
- Ejection fraction ≥ 45%
- No significant history of non-compliance to medical regimens or inability to give reliable informed consent
- PRIOR CONCURRENT THERAPY:
- Previous treatment related toxicities should be resolved to grade 1 or better
- No other investigational agents within 14 days prior to the start of study
- No chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to start of study
- No major surgery within 2 weeks prior to start of study
- At least two weeks must have elapsed since the conclusion of radiation therapy and the start of gemcitabine hydrochloride, provided the acute effects of radiation treatment have been resolved
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00268242
Start Date
January 1 2006
End Date
July 1 2011
Last Update
February 22 2018
Active Locations (2)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
2
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195