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

Acute Myelogenous Leukemia Clinical Trial

Official title:

High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136448
• Other study ID #: 92-148
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2005
• Last updated: March 9, 2011
• Start date: February 1993
• Est. completion date: September 2007

Study information

• Verified date: March 2011
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• cytosine arabinoside (ara-C)

• daunomycin

• interleukin-2

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To assess additional immunologic effects of IL-2
Secondary	To obtain preliminary data regarding the rate of disease relapse