Acute Myelogenous Leukemia Clinical Trial
Official title:
High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission
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 |
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital |
United States,
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 |
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