Clinical trial NCT00136448: High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)
Official title: High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Keywords: AML
acute myelogenous leukemia
cytarabine
interleukin-2
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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 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.

Primary outcomes:
measure: 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 outcomes:
measure: 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
measure: To assess additional immunologic effects of IL-2
measure: To obtain preliminary data regarding the rate of disease relapse
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Richard M. Stone, MD
role: PRINCIPAL_INVESTIGATOR
References: