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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
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 |
Biological: aldesleukin Biological: filgrastim Drug: busulfan Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Procedure: peripheral blood stem cell transplantation |
Phase III |
| 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 |
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
Hide Study Locations| United States, California | |
| Naval Medical Center - San Diego | |
| San Diego, California, United States, 92134 | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Veterans Affairs Medical Center - San Diego | |
| San Diego, California, United States, 92161 | |
| United States, Delaware | |
| Beebe Medical Center | |
| Lewes, Delaware, United States, 19958 | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| St. Francis Hospital | |
| Wilmington, Delaware, United States, 19805 | |
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Florida | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| United States, Illinois | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Galesburg Clinic | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| InterCommunity Cancer Center of Western Illinois | |
| Galesburg, Illinois, United States, 61401 | |
| Kewanee Hospital | |
| Kewanee, Illinois, United States, 61443 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| University of Illinois Cancer Center | |
| Chicago, Illinois, United States, 60612-7243 | |
| Valley Cancer Center | |
| Spring Valley, Illinois, United States, 61362 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology | |
| Fort Wayne, Indiana, United States, 46815 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medial Center | |
| Bangor, Maine, United States, 04401 | |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | |
| Scarborough, Maine, United States, 04074 | |
| United States, Maryland | |
| Union Hospital Cancer Center at Union Hospital | |
| Elkton MD, Maryland, United States, 21921 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| Fairview University Medical Center - University Campus | |
| Minneapolis, Minnesota, United States, 55455 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| St Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Methodist Cancer Center at Methodist Hospital - Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| Sunrise Hospital and Medical Center | |
| Las Vegas, Nevada, United States, 89109 | |
| University Medical Center of Southern Nevada | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Hampshire | |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | |
| Keene, New Hampshire, United States, 03431 | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11042 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Wayne Radiation Oncology | |
| Goldsboro, North Carolina, United States, 27534 | |
| Wilson Medical Center | |
| Wilson, North Carolina, United States, 27893-3428 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Pennsylvania | |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224-1791 | |
| United States, Rhode Island | |
| Comprehensive Cancer Center at Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Miriam Hospital at Lifespan | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| Mountainview Medical | |
| Berlin, Vermont, United States, 05602 | |
| United States, Virginia | |
| Massey Cancer Center at Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298-0037 | |
| Rappahannock General Hospital | |
| Kilmarnock, Virginia, United States, 22482 | |
| 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
| Study ID Numbers: | CDR0000068234, CALGB-19808 |
| Study First Received: | October 4, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006363 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated adult acute myeloid leukemia adult acute erythroid leukemia (M6) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute eosinophilic leukemia adult acute basophilic leukemia |
adult acute megakaryoblastic leukemia (M7) adult acute monocytic leukemia (M5b) adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
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Antimetabolites Anti-Infective Agents Daunorubicin Anti-HIV Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid Antibiotics, Antineoplastic |
Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Leukemia Neoplasms Aldesleukin Anti-Retroviral Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Etoposide Cytarabine |