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NCT Number: NCT00874562

Rapamycin in Relapsed Acute Lymphoblastic Leukemia

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

365 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corticosteroid

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

Drug

Taken orally mixed with water or orange juice

Other names: sirolimus

Primary outcomes

  1. Compare changes in gene expression signatures in steroid alone versus steroid plus rapamycin treated patients.

    Time frame: 3 years

  2. Compare biologic measures of "pro-apoptotic state" in steroid alone versus steroid plus rapamycin treated patients

    Time frame: 3 years

Secondary outcomes

  1. Assess clinical response by percent reduction of peripheral leukemia blasts at day 2 of therapy and at completion of the 5-day investigational window

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Boston Children's Hospital
  • Brigham and Women's Hospital
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2016
First posted
Apr 2, 2009
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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