Rapamycin in Relapsed Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Rapamycin in Relapsed Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874562
• Other study ID #: 06-429
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2009
• Last updated: November 21, 2016
• Start date: July 2007
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

• Participants will be randomized into two groups; one group will receive corticosteroid alone, and the other group will receive rapamycin and corticosteroid.

• The length of treatment will be 5 days, during which time we will collect blood samples to measure the biologic effects of these drugs. Because these drugs will be given for a short period of time only, this study is not designed to treat or cure the participants leukemia. After the 5-day period, participants may resume other cancer-directed therapies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2016
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 365 Days and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Corticosteroid
Initial dose of corticosteroid given intravenously. After the first dose, corticosteroid will be taken orally every 8 hours for the duration of the five-day period
• Rapamycin
Taken orally mixed with water or orange juice

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Boston Children’s Hospital, Brigham and Women's Hospital, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare changes in gene expression signatures in steroid alone versus steroid plus rapamycin treated patients.		3 years	No
Primary	Compare biologic measures of "pro-apoptotic state" in steroid alone versus steroid plus rapamycin treated patients		3 years	No
Secondary	Assess clinical response by percent reduction of peripheral leukemia blasts at day 2 of therapy and at completion of the 5-day investigational window		3 years	No