Clofarabine in Adult Patients With Advanced Solid Tumors
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This research study of clofarabine will be used for advanced cancer in persons in which drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions:
- What is the largest dose of clofarabine that can be safely administered as an IV infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by 1 week of rest and repeated every 28 days?
- What are the side effects of clofarabine when given on this schedule?
- How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? Once the MTD/RP2D is established, patients will be enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every other cycle.
- Will clofarabine help treat a specific cancer?
Leukemia, Lymphocytic, Acute, Pediatric
Leukemia, Lymphocytic, Acute, Adult
Leukemia, Myelocytic, Acute, Pediatric
Leukemia, Myelocytic, Acute, Adult
Myelodysplastic Syndromes, Adult
Drug: clofarabine (IV formulation)
|Official Title:||A Phase I and Pharmacokinetic Study of Clofarabine in Adult Patients With Advanced Solid Tumors|
- The maximum tolerated dose (MTD)/recommended phase II dose (RP2D) is the dose at which less than or equal to 1 of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.
|Study Start Date:||August 2002|
|Study Completion Date:||August 2007|
|United States, Texas|
|Mary Crowley Medical Research Center|
|Dallas, Texas, United States, 75246|
|US Oncology Tyler Cancer Center|
|Tyler, Texas, United States, 75702|