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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00136448 |
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 |
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Acute Myelogenous Leukemia |
Drug: cytosine arabinoside (ara-C) Drug: daunomycin Drug: interleukin-2 |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Richard M. Stone, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | 92-148 |
Study First Received: | August 25, 2005 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00136448 History of Changes |
Health Authority: | United States: Institutional Review Board |
AML acute myelogenous leukemia cytarabine interleukin-2 |
Antimetabolites Daunorubicin Anti-Infective Agents Immunologic Factors Leukemia, Myeloid Leukemia, Myeloid, Acute Antiviral Agents Immunosuppressive Agents Anti-Bacterial Agents |
Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Analgesics, Non-Narcotic Interleukin-2 Peripheral Nervous System Agents Analgesics Cytarabine |
Antimetabolites Daunorubicin Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Antibiotics, Antineoplastic Leukemia Sensory System Agents Therapeutic Uses |
Analgesics Cytarabine Neoplasms by Histologic Type Leukemia, Myeloid Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Interleukin-2 Analgesics, Non-Narcotic Peripheral Nervous System Agents Central Nervous System Agents |