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A Phase I Trial of Temsirolimus (CCI-779, Pfizer, Inc.) in Combination With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

Status
Active
Cancer Type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Trial Phase
Phase I
Eligibility
1 to 21, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01614197
Protocol IDs
T2014-001 (primary)
NCI-2012-01493
T2008-004
Study Sponsor
Therapeutic Advances in Childhood Leukemia Consortium

Summary

This is a phase I study of temsirolimus (Torisel) combined with dexamethasone,

cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL),

lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).

Objectives

Studies have shown that mTOR inhibitors (MTI) inhibit growth of pre-B and T-cell ALL cell

lines in vitro and in ALL xenograft models. The MTI temsirolimus was chosen for use in this

study due to its weekly intravenous dosing, its more predictable blood levels, and

availability of a single-agent pediatric MTD and its sustained biologic effect due to

conversion to sirolimus. This study will determine the maximum tolerated dose of

temsirolimus that can given in combination with dexamethasone, cyclophosphamide and

etoposide in relapsed ALL, LL or PTL. A standard 3-patient cohort dose-escalation design

will be used. Response to treatment will be evaluated. Biology tests will be done to

evaluate minimal residual disease (MRD), temsirolimus' effect on glucocorticoid resistance,

and mTOR inhibition.

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