Rapamycin in Relapsed Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a research study designed to look at the biological effects of two drugs on leukemia cells. In this study, we are comparing the effects of drugs called corticosteroids when used alone or with another drug called rapamycin. Rapamycin is a drug that prevents the body's immune system from working normally. It has been used for many years after kidney transplants to prevent rejection of the organ. Recent work suggests that rapamycin may also help treat leukemia and other cancers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Boston Children's Hospital; Boston Children’s Hospital; Brigham and Women's Hospital; National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Documented acute lymphoblastic leukemia (L1 or L2 subtypes)

• First or subsequent relapse

• 365 days of age or older

• Greater than 7 days from any chemotherapy or immunotherapy, with the exception of intrathecal chemotherapy

• Absolute peripheral leukemia blast count of 1000 cells/ul or greater

• Patient (or parent/guardian if patient is less than 18 years of age) must sign informed consent

Exclusion Criteria:

• Burkitts leukemia (acute lymphoblastic leukemia L3 subtype)

• Uncontrolled active infection

• Pregnancy or mothers who are nursing

• Patient currently taking rapamycin

• Patients with significant liver dysfunction as outlined in protocol

• Severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into the study

• Active psychiatric disease, substance abuse, or mental illness that would interfere with cooperation with the requirements of the trial