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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006363 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy together with PSC 833 followed by a peripheral stem cell transplant with or without interleukin-2 to see how well it works compared to combination chemotherapy alone followed by a peripheral stem cell transplant with or without interleukin-2 in treating patients with acute myeloid leukemia.
| Condition | Intervention | Phase |
|
Leukemia |
Drug: aldesleukin Drug: busulfan Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: filgrastim Procedure: peripheral blood stem cell transplantation |
Phase III |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| ChemIDplus related topics: | Filgrastim Cytarabine Cytarabine hydrochloride Etoposide Daunorubicin hydrochloride Daunorubicin Aldesleukin Etoposide phosphate Busulfan Sdz psc 833 Interleukin-2 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Randomized Study Of Induction Chemotherapy With or Without MDR-Modulation With PSC-833 (NSC #648265, IND #41121) Followed By Cytogenetic Risk-Adapted Intensification Therapy Followed By Immunotherapy With RIL-2 (NSC #373364, IND #1969) vs. Observation In Previously Untreated Patients With AML < 60 Years |
| Estimated Enrollment: | 720 |
| Study Start Date: | November 2000 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 15 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia (AML) with more than 20% blasts in bone marrow by WHO and/or FAB classifications
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Other concurrent myeloid growth factors allowed only if prognostic factors predictive of clinical deterioration are present such as the following:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations![]() |
Show 79 Study Locations |
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Jonathan E. Kolitz, MD | Don Monti Comprehensive Cancer Center at North Shore University Hospital |
| Investigator: | Richard A. Larson, MD | University of Chicago |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Kolitz JE, Hars V, DeAngelo DJ, et al.: Phase III trial of immunotherapy with recombinant interleukin-2 (rIL-2) versus observation in patients < 60 years with acute myeloid leukemia (AML) in first remission (CR1): preliminary results from Cancer and Leukemia Group B (CALGB) 19808. [Abstract] Blood 110 (11): A-157, 2007.
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Radmacher MD, Marcucci G, Paschka P, et al.: MicroRNA (miR) expression signatures in molecular subsets of cytogenetically normal (CN) acute myeloid leukemia (AML): a Cancer and Leukemia Group B (CALGB) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-7010, 359s, 2007.
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Kolitz JE, George SL, Marcucci G, et al.: A randomized comparison of induction therapy for untreated acute myeloid leukemia (AML) in patients < 60 years using p-glycoprotein (Pgp) modulation with valspodar (PSC833): preliminary results of Cancer and Leukemia Group B study 19808. [Abstract] Blood 106 (11): A-407, 2005.
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| Study ID Numbers: | CDR0000068234, CALGB-19808 |
| First Received: | October 4, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006363 |
| Health Authority: | United States: Federal Government |
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