drugset / Trial / NCT01184885
A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy
Phase 0
Completed
7 enrolled
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
American Society of Clinical Oncology · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a pilot study, assessing the feasibility, safety and toxicity of an mTOR (mammalian target of Rapamycin) inhibitor (MTI), rapamycin, when administered with HyperCVAD (Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicine and Dexamethasone), with an ultimate goal to perform a phase II study to evaluate response rates and survival in adults with Acute Lymphoblastic Leukemia (ALL) and aggressive lymphoid malignancies.
Timeline
- Start
- 2010-07
- Primary completion
- 2011-03
- Completion
- 2013-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sirolimus | Small molecule | 4 mg | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Cytarabine | Small molecule | 100 mg | Intrathecal |
| Background | Cytarabine | Small molecule | 3000 mg/m2 | Intrathecal |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Background | Leucovorin | Small molecule | 50 mg | — |
| Background | Methotrexate | Small molecule | 12 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 1000 mg/m2 | Intrathecal |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Vincristine | Small molecule | 2 mg | — |