Spots Global Cancer Trial Database for A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma
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Trial Identification
Brief Title: A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma
Official Title: 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
Study ID: NCT01614197
Study Description
Brief 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).
Detailed Description: 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.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital Orange County, Orange, California, United States
UCSF School of Medicine, San Francisco, California, United States
The Children's Hospital, University of Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Miami Cancer Center, Miami, Florida, United States
Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia, United States
Lurie Children's Hospital, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana Farber, Boston, Massachusetts, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
Childrens Hospital & Clinics of Minnesota, Minneapolis, Minnesota, United States
Children's Hospital New York-Presbyterian, New York, New York, United States
Levine Children's Hospital at Carolinas Medical Center, Charlotte, North Carolina, United States
Rainbow Babies, Cleveland, Ohio, United States
Nationwide Childrens Hospital, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Jude, Memphis, Tennessee, United States
University of Texas at Southwestern, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Texas Children's Hospital, Houston, Texas, United States
Primary Children's, Salt Lake City, Utah, United States
Seattle Children's Hospital, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Children's Hospital at Westmead, Westmead, New South Wales, Australia
Royal Children's Hospital, Brisbane, Queensland, Australia
Royal Children's Hospital, Melbourne, Melbourne, Victoria, Australia
Sydney Children's Hospital, Sydney, , Australia
Hospital for Sick Kids, Toronto, Ontario, Canada
Sainte Justine University Hospital, Montreal, Quebec, Canada
British Columbia Children's Hospital, Vancouver, , Canada
Contact Details
Name: Susan Rheingold, MD
Affiliation: Children's Hospital of Philadelphia
Role: STUDY_CHAIR
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