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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

Cancer Type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Trial Phase
Phase I
1 to 21, Male and Female
Study Type
Biomarker/Laboratory analysis
Protocol IDs
T2014-001 (primary)
Study Sponsor
Therapeutic Advances in Childhood Leukemia Consortium


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).


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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