drugset / Trial / NCT01324180
Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL)
Phase 1
Completed
14 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Pediatric Cancer Foundation · collab
NaSingle-groupOpen-labelTreatment
Summary
H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator, but will not be recruiting locally. The purpose of the trial is to study the clinical and biological effects of metformin in combination with standard systemic chemotherapy in a disease (relapsed ALL) that has a dismal outcome, as well as to do a dose escalation study to find the Maximum Tolerated Dose (MTD) of metformin in conjunction with ALL therapy. There have also been analysis of patients enrolled on trials who were diabetics on metformin and their outcome was better than patients on the same trial that were not on metformin as their antihyperglycemic.
Timeline
- Start
- 2011-07-18
- Primary completion
- 2016-11-16
- Completion
- 2017-07-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | — | Oral |
| Background | Cytarabine | Small molecule | 30 mg | Intrathecal |
| Background | Cytarabine | Small molecule | 50 mg | Intrathecal |
| Background | Cytarabine | Small molecule | 70 mg | Intrathecal |
| Background | Dexamethasone | Small molecule | 10 mg/m2 | Oral |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 unknown | Intramuscular |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | Intravenous |