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

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00136448
First received: August 25, 2005
Last updated: March 9, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Acute Myelogenous Leukemia
Drug: cytosine arabinoside (ara-C)
Drug: daunomycin
Drug: interleukin-2
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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:
  • 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
  • To assess additional immunologic effects of IL-2
  • To obtain preliminary data regarding the rate of disease relapse

Estimated Enrollment: 30
Study Start Date: February 1993
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136448

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Richard M. Stone, MD Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136448     History of Changes
Other Study ID Numbers: 92-148
Study First Received: August 25, 2005
Last Updated: March 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
AML
acute myelogenous leukemia
cytarabine
interleukin-2

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Interleukin-2
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014