Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT01820624 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2017-04-27
Summary
This phase I trial studies the side effects and best dose of tretinoin when given together with lithium carbonate in treating patients with relapsed or refractory acute myeloid leukemia. Lithium carbonate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Tretinoin may help \[type of cancer\] cells become more like normal cells, and to grow and spread more slowly. Giving lithium carbonate together with tretinoin may kill more cancer cells
Conditions
- Adult Acute Megakaryoblastic Leukemia (M7)
- Adult Acute Monoblastic Leukemia (M5a)
- Adult Acute Monocytic Leukemia (M5b)
- Adult Acute Myeloblastic Leukemia With Maturation (M2)
- Adult Acute Myeloblastic Leukemia Without Maturation (M1)
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Adult Acute Myelomonocytic Leukemia (M4)
- Adult Erythroleukemia (M6a)
- Adult Pure Erythroid Leukemia (M6b)
- Recurrent Adult Acute Myeloid Leukemia
Interventions
- DRUG
-
tretinoin
Given PO
- DRUG
-
lithium carbonate
Given PO
- OTHER
-
laboratory biomarker analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Paolo Caimi, MD
lead OTHER
Principal Investigators
-
Paolo Caimi, MD · University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2015-10-09
- Completion
- 2015-11-13
Countries
- United States
Study Locations
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