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
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 |
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
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 |