We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rapamycin in Relapsed Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874562
First Posted: April 2, 2009
Last Update Posted: November 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Boston Children’s Hospital
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lewis B. Silverman, M.D., Dana-Farber Cancer Institute
  Purpose
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.

Condition Intervention Phase
Acute Lymphoblastic Leukemia Drug: Corticosteroid Drug: Rapamycin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Rapamycin in Relapsed Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Lewis B. Silverman, M.D., Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Compare changes in gene expression signatures in steroid alone versus steroid plus rapamycin treated patients. [ Time Frame: 3 years ]
  • Compare biologic measures of "pro-apoptotic state" in steroid alone versus steroid plus rapamycin treated patients [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: July 2007
Study Completion Date: April 2016
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Steroid Only
Corticosteroid Alone
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
Active Comparator: Steroid plus Rapamycin
Corticosteroid plus Rapamycin
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
Drug: Rapamycin
Taken orally mixed with water or orange juice
Other Name: sirolimus

Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   365 Days and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874562


Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Boston Children’s Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lewis Silverman, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Lewis B. Silverman, M.D., Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00874562     History of Changes
Other Study ID Numbers: 06-429
First Submitted: April 1, 2009
First Posted: April 2, 2009
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lewis B. Silverman, M.D., Dana-Farber Cancer Institute:
rapamycin
corticosteroid
ALL

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs