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T2014-001 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
Protocol Number:
Phase I
Patrick Brown
Johns Hopkins Kimmel Cancer Center in Baltimore
This study is being carried out by the Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) Consortium. TACL is a group of Universities and Children’s Hospitals that are working together to find treatments for children with leukemia and lymphoma. This is a phase I study of a drug called temsirolimus in combination with intensive cytotoxic chemotherapy consisting of cyclophosphamide and etoposide. Temsirolimus is approved by the Food and Drug Administration (FDA) for the treatment of advanced renal cell carcinoma. It is not approved for use in leukemia or lymphoma. The FDA is allowing the use of temsirolimus in this research study. We are using temsirolimus because it seems to work against cancer in cells and animals. We do not know if temsirolimus will work in people. Temsirolimus has been used in only a small number of adults and children and there is a lot that we do not know about it yet. This is called a Phase I study because the goal is to find the highest dose of temsirolimus that we can give safely in combination with intensive chemotherapy.We are testing new experimental drug combinations such as the combination of temsirolimus, cyclophosphamide and etoposide in the hopes of finding a drug combination that may be effective against relapsed leukemia and non-hodgkins lymphoma.The goals of this study are:•To find the highest safe dose of temsirolimus that can be given with intensive chemotherapy without causing severe side effects;•To learn what kind of side effects temsirolimus can cause;•To learn more about the pharmacology (how your body handles the drug) of temsirolimus;•To learn how temsirolimus affects specific molecules on leukemia and lymphoma cells; •To determine whether temsirolimus, combined with intensive chemotherapy, is a beneficial treatment for leukemia and lymphoma.
Patients must be equal to 12 months and equal to 21 years of age at the time of study enrollment. People with ALL, Lymphoblastic Lymphoma or Peripheral T-Cell Lymphoma that has come back (relapsed) may join. Patients must have had two or more prior attempts at remission. At least 84 days must have elapsed since a stem cell (bone marrow) transplant.
Temsirolimus will be given by intravenous (IV) infusion on days 1 and 8. Cyclophosphamide and etoposide will be given by intravenous (IV) infusion on days 1-5. Intrathecal cytarabine or triple intrathecal therapy is given based on whether there is disease in the central nervous system at the time of study entry. Patients will then recover from the combined therapy. A cycle lasts approximately 4 weeks and patients may get up to 8 cycles as long as they have stable or improving cancer.
Last Update
08/07/2020 05:02 AM