Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL

Status: Recruiting
Phase: Phase 1
Diagnosis: Pediatric Leukemia
NCT ID: NCT01523977 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-237

 

Laboratory and other studies suggest that, the study drug, Everolimus (RAD001), may prevent tumor cell growth and also may increase the efficacy of other chemotherapy drugs. Everolimus is approved for use in the United States for certain types of cancer, such as kidney cancer. It has been extensively studied in people with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of other drugs. Studies in adults with cancer have also evaluated Everolimus in combination with other anti-tumor drugs. Information from lab studies and some other clinical trials suggests that Everolimus may kill leukemia cells on its own, and also make it more likely that steroids (such as prednisone) are able to kill leukemia cells. In this research study, we are looking to learn more about how Everolimus works in combination with other drugs which are commonly used to treat relapsed acute lymphoblastic leukemia (prednisone, vincristine, PEG-asparaginase, and doxorubicin). The main goal of the study is to evaluate the side effects of this treatment combination in order to determine a safe dose of Everolimus which can be given with these other 4 drugs.

 

Conducting Institutions:
Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:
Lewis Silverman, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - ALL in first bone marrow relapse occuring > 18 months from initial diagnosis - Normal organ function - Maximum prior cumulative doxorubicin dose of </= 360 mg/m2 or equivalent Exclusion Criteria: - Prior therapy for ALL except for intrathecal (IT) chemotherapy - Pregnant or lactating - Individuals whose relapsed ALL harbors a t(9;22)/BCR-ABL fusion - Individuals whose lymphoblasts have surface immunoglobulin by flow cytometry and/or t(8;14), t(2;8), or t(8;22) - Down syndrome - Prior stem cell transplant - History of asparaginase-associated pancreatitis - Active lung disease - Impairment of gastrointestinal function or gastrointestinal disease - Severe and/or uncontrolled intercurrent illness - Documented history of previous or current Hepatitis B or C infection - History of a different malignancy (other than ALL) unless disease-free for at 5 years and deemed by the investigators to be at low risk for recurrence of that malignancy - HIV positive on combination antiretroviral therapy
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