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High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)

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. Identifier: NCT00136448
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : March 10, 2011
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
This study will add interleukin-2 (IL-2) to a regimen of post-remission therapy consisting of high-dose ara-C. Patients with AML in first remission will receive 3 cycles of high-dose ara-C followed by continuous infusion and bolus interleukin-2 (IL-2). We, the researchers at the Dana-Farber Cancer Institute, plan to evaluate the immunologic effects of such treatment in these patients.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: cytosine arabinoside (ara-C) Drug: daunomycin Drug: interleukin-2 Phase 2

Detailed Description:

Patients will receive standard remission induction therapy with daunorubicin at a dose of 45 mg/m2/day for 3 days and continuous infusion cytarabine at a dose of 200 mg/m2/day for 7 days.

Those patients who enter a remission status and have preserved liver and kidney function will then receive 3 cycles of post-remission therapy that will consist of high-dose cytarabine at a dose of 3000 mg/m2 every 12 (q12) hours on days 1, 3 and 5 (total of 6 doses).

Patients who are still in remission will receive interleukin-2 (IL-2) upon count recovery at a dose of 8.1 X 10^5 U/m2/day by continuous infusion for 10 weeks. In addition, patients will receive bolus IL-2 at a dose of 6 X 10^5 U/m2 by intravenous bolus weekly for 6 doses through day 63.

Patients will be seen on a weekly basis while on treatment for examination and bloodwork.

At the end of treatment, patients will have a physical exam and bloodwork performed monthly for two years, then 4 times per year for two years.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission
Study Start Date : February 1993
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  1. The primary purpose of this study is to evaluate the ability of IL-2 to generate cytotoxic and inhibitory activity against cryopreserved autologous leukemic myeloblasts obtained at the time of diagnosis.

Secondary Outcome Measures :
  1. To evaluate the safety of continuous infusion IL-2 with intermittent IL-2 boluses in patients with AML who have received 3 cycles of post-remission intensification therapy with high-dose ara-C
  2. To assess additional immunologic effects of IL-2
  3. To obtain preliminary data regarding the rate of disease relapse

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have AML based on French-American-British (FAB) criteria.
  • Patients must have a total bilirubin of < 2.0 mg/dL, SGOT < 90 IU/mL, alkaline phosphatase < 250 U/mL and a serum creatinine < 2.0 mg/dL.
  • Age 18 years or greater.

Exclusion Criteria:

  • History of an antecedent hematologic malignancy such as myelodysplastic syndromes (MDS).
  • Uncontrolled infection.
  • History of a previous or concomitant malignancy other than non-melanoma skin cancer.
  • Evidence of central nervous system (CNS) leukemia.
  • Current use of corticosteroids.
  • Prior treatment for AML, other than hydroxyurea.

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 identifier (NCT number): NCT00136448

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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
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Principal Investigator: Richard M. Stone, MD Dana-Farber Cancer Institute
Layout table for additonal information Identifier: NCT00136448    
Other Study ID Numbers: 92-148
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011
Keywords provided by Dana-Farber Cancer Institute:
acute myelogenous leukemia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors