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Rapamycin in Relapsed Acute Lymphoblastic Leukemia

NCT ID: NCT00874562

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Acute Lymphoblastic Leukemia

Keywords

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rapamycin corticosteroid ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Steroid Only

Corticosteroid Alone

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type DRUG

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

Steroid plus Rapamycin

Corticosteroid plus Rapamycin

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type DRUG

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

Intervention Type DRUG

Taken orally mixed with water or orange juice

Interventions

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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

Intervention Type DRUG

Rapamycin

Taken orally mixed with water or orange juice

Intervention Type DRUG

Other Intervention Names

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sirolimus

Eligibility Criteria

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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
Minimum Eligible Age

365 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Lewis B. Silverman, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lewis Silverman, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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06-429

Identifier Type: -

Identifier Source: org_study_id