drugset / Trial / NCT01403415

Temsirolimus, Dexamethasone, Mitoxantrone Hydrochloride, Vincristine Sulfate, and Pegaspargase in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

NCT01403415

Phase 1 Completed 13 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and the best dose of temsirolimus when given together with dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase in treating young patients with relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus with combination chemotherapy may be and effective treatment for acute lymphoblastic leukemia or non-Hodgkin lymphoma.

Timeline

Start
2011-09
Primary completion
2015-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Temsirolimus Small molecule Intravenous
Background Dexamethasone Small molecule Oral
Background Methotrexate Small molecule Intrathecal
Background Mitoxantrone Small molecule Intravenous
Background Pegaspargase Protein / enzyme biologic Intravenous
Background Vincristine Small molecule Intravenous