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Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
This study is ongoing, but not recruiting participants.
First Received: October 4, 2000   Last Updated: February 6, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of disease-free and overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed acute myeloid leukemia (AML) with more than 20% blasts in bone marrow by WHO and/or FAB classifications

    • Antecedent myelodysplasia allowed if there was no bone marrow biopsy showing myelodysplastic syndromes over the previous 3 months
    • No acute promyelocytic leukemia (M3)
    • No therapy-related myelodysplastic syndromes or AML
    • No chronic myeloproliferative disorder
  • Must also be enrolled on CALGB 9665 unless inaspirable and mandatory leukemic cells cannot be obtained from the blood

PATIENT CHARACTERISTICS:

Age:

  • 15 to 59

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior emergency leukapheresis allowed
  • Prior growth factor/cytokine support allowed
  • No other prior biologic therapy
  • Other concurrent myeloid growth factors allowed only if prognostic factors predictive of clinical deterioration are present such as the following:

    • Pneumonia
    • Hypotension
    • Multiorgan dysfunction (sepsis syndrome)
    • Fungal infection

Chemotherapy:

  • Prior emergency treatment for hyperleukocytosis with hydroxyurea allowed
  • No other prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • No prior endocrine therapy
  • No concurrent hormonal therapy other than steroids for adrenal failure or septic shock or hormones for conditions not related to disease (e.g., insulin for diabetes or estrogens or progestins for gynecologic indications)

Radiotherapy:

  • One dose of prior cranial radiotherapy for CNS leukostasis allowed
  • No other prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006363

  Hide Study Locations
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
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
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

Additional Information:
Publications:
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.
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.
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.
Langer C, Maharry K, Mrózek K, et al.: Low Meningioma 1 (MN1) gene expression to predict outcome in cytogenetically normal acute myeloid leukemia (CN-AML): A Cancer and Leukemia Group B (CALGB) study. [Abstract] J Clin Oncol 26 (Suppl 15): A-7011, 2008.
Langer C, Radmacher MD, Ruppert AS, Whitman SP, Paschka P, Mrozek K, Baldus CD, Vukosavljevic T, Liu CG, Ross ME, Powell BL, de la Chapelle A, Kolitz JE, Larson RA, Marcucci G, Bloomfield CD. High BAALC expression associates with other molecular prognostic markers, poor outcome and a distinct gene-expression signature in cytogenetically normal acute myeloid leukemia: a Cancer and Leukemia Group B (CALGB) study. Blood. 2008 Mar 31; [Epub ahead of print]
Marcucci G, Maharry K, Radmacher MD, Mrózek K, Vukosavljevic T, Paschka P, Whitman SP, Langer C, Baldus CD, Liu CG, Ruppert AS, Powell BL, Carroll AJ, Caligiuri MA, Kolitz JE, Larson RA, Bloomfield CD. Prognostic Significance of, and Gene and MicroRNA Expression Signatures Associated With, CEBPA Mutations in Cytogenetically Normal Acute Myeloid Leukemia With High-Risk Molecular Features: A Cancer and Leukemia Group B Study. J Clin Oncol. 2008 Sep 22; [Epub ahead of print]
Paschka P, Marcucci G, Ruppert AS, Whitman SP, Mrózek K, Maharry K, Langer C, Baldus CD, Zhao W, Powell BL, Baer MR, Carroll AJ, Caligiuri MA, Kolitz JE, Larson RA, Bloomfield CD. Wilms Tumor 1 Gene Mutations Independently Predict Poor Outcome in Adults With Cytogenetically Normal Acute Myeloid Leukemia: A Cancer and Leukemia Group B Study. J Clin Oncol. 2008 Jun 16; [Epub ahead of print]
Langer C, Ruppert, AS, Radmacher MD, et al.: High BAALC expression associates with other molecular prognostic markers, poor outcome and a distinct gene expression signature in cytogenetically normal acute myeloid leukemia (CN AML): a Cancer and Leukemia Group B (CALGB) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-7013, 360s, 2007.
Marcucci G, Maharry K, Radmacher MD, et al.: Gene and microRNA (miRNA) expression signatures and prognostic significance of CEBPA mutations in cytogenetically normal (CN) acute myeloid leukemia (AML) with high-risk molecular features: a Cancer and Leukemia Group B (CALGB) study . [Abstract] Blood 110 (11): A-104, 2007.
Marcucci G, Maharry K, Whitman SP, Vukosavljevic T, Paschka P, Langer C, Mrozek K, Baldus CD, Carroll AJ, Powell BL, Kolitz JE, Larson RA, Bloomfield CD. High Expression Levels of the ETS-Related Gene, ERG, Predict Adverse Outcome and Improve Molecular Risk-Based Classification of Cytogenetically Normal Acute Myeloid Leukemia: A Cancer and Leukemia Group B Study. J Clin Oncol. 2007 Jun 18; [Epub ahead of print]
Whitman SP, Ruppert AS, Marcucci G, Mrozek K, Paschka P, Langer C, Baldus CD, Wen J, Vukosavljevic T, Powell BL, Carroll AJ, Kolitz JE, Larson RA, Caligiuri MA, Bloomfield CD. Long-term disease-free survivors with cytogenetically normal acute myeloid leukemia and MLL partial tandem duplication: a Cancer and Leukemia Group B study. Blood. 2007 Mar 6; [Epub ahead of print]
Paschka P, Marcucci G, Ruppert AS, Mrozek K, Chen H, Kittles RA, Vukosavljevic T, Perrotti D, Vardiman JW, Carroll AJ, Kolitz JE, Larson RA, Bloomfield CD; Cancer and Leukemia Group B. Adverse prognostic significance of KIT mutations in adult acute myeloid leukemia with inv(16) and t(8;21): a Cancer and Leukemia Group B Study. J Clin Oncol. 2006 Aug 20;24(24):3904-11.
Kolitz JE, George SL, Baer MR, Lee EJ, Bloomfield CD, Larson RA; Cancer and Leukemia Group B (CALGB) trials in younger and older adults. P-glycoprotein (Pgp) modulation in untreated acute myeloid leukemia (AML): Cancer and Leukemia Group B (CALGB) trials in younger and older adults. Ann Hematol. 2004;83 Suppl 1:S103-4. No abstract available.

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

Keywords provided by National Cancer Institute (NCI):
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)

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009