T2014-001, A Phase 1 Trial of Temsirolimus (CCI-779, Pfizer, Inc.) in Combination with Etoposide and Cyclophosphamide in Children with Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma
Study of Combination Therapies in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkins Lymphoma (NHL)
Sponsor: Therapeutic Advances in Childhood Leukemia and Lymphoma Consortium
Enrolling: Male and Female Patients
IRB Number: AAAQ6290
U.S. Govt. ID: NCT01614197
Contact: Rebecca Zylber, NP: 212-305-7212 / rjv2107@cumc.columbia.edu
Additional Study Information: This is a Phase 1 multicenter study of temsirolimus in combination with etoposide and cyclophosphamide. The study treatment is considered experimental because it is not approved by the Unites States (US) Food and Drug Administration (FDA) for treating children with acute lymphoblastic leukemia (ALL) and non-Hodgkins lymphoma (NHL) who have relapsed. The purpose of this study is to determine the maximum tolerated dose (MTD) of temsirolimus when combined with etoposide and cyclophosphamide in pediatric and young adult patients with relapsed ALL or NHL and to evaluate the toxicities and potential antitumor activity of temsirolimus when given in combination with etoposide and cyclophosphamide in children with refractory ALL and NHL.
This study is closed
Investigator
Nobuko Hijiya, MD
Do You Qualify?
Is your child between the ages of 12 months and 21 years of age? Yes No
Does your child have acute lymphoblastic leukemia (ALL) or lymphoma? Yes No
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For more information, please contact:
Rebecca Zylber, NP
rjv2107@cumc.columbia.edu
212-305-7212