Recurrent Childhood Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase 1 Study of Temsirolimus in Combination With Intensive Re-induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma
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.
PRIMARY OBJECTIVES:
I. To estimate the maximum-tolerated dose (MTD) and/or recommended phase 2 dose of
temsirolimus administered weekly for 2 doses in combination with intensive re-induction
chemotherapy in children with relapsed acute lymphoblastic leukemia (ALL) or non-Hodgkin
lymphoma (NHL).
II. To define and describe the toxicities of temsirolimus in combination with intensive
re-induction chemotherapy in children with relapsed ALL or NHL administered on this
schedule.
SECONDARY OBJECTIVES:
I. To compare minimal-residual disease (MRD) levels present at end of induction to
historical control in patients with relapsed ALL or NHL with bone marrow involvement of
disease.
II. To determine the complete remission (CR) rate in patients with ALL or NHL who receive
this regimen.
III. To evaluate responsiveness of patient ALL cells to mammalian target of rapamycin (mTOR)
inhibition using in vitro and in vivo pharmacodynamic assessment of the response of ALL
blasts to temsirolimus.
OUTLINE: This is a dose-escalation study of temsirolimus.
Patients receive dexamethasone orally (PO) or intravenously (IV) on days 1-5 and 15-19;
mitoxantrone hydrochloride IV over 30 minutes on days 1-2; temsirolimus IV over 30 minutes
on days 1 and 8; vincristine sulfate IV on days 1, 8, 15, and 22; and pegaspargase IV over 1
hour on days 3 and 17. Some patients may also receive methotrexate intrathecally (IT) up to
72 hours prior to or on day 1 and on day 8.
After completion of study therapy, patients are followed up for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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