- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136448
High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)
High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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
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To assess additional immunologic effects of IL-2
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To obtain preliminary data regarding the rate of disease relapse
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard M. Stone, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cytarabine
- Daunorubicin
- Interleukin-2
Other Study ID Numbers
- 92-148
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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