Clinical Trial: 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 currently recruiting patients.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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: Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without PSC 833, peripheral stem cell transplantation, and interleukin-2 in treating patients who have acute myeloid leukemia.

Condition Treatment or Intervention Phase
adult acute monoblastic and acute monocytic leukemia
adult acute myeloid leukemia
 Drug: busulfan
 Drug: cytarabine
 Drug: daunorubicin
 Drug: etoposide
 Drug: filgrastim
 Drug: interleukin-2
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemosensitization/potentiation
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: interleukin therapy
 Procedure: peripheral blood stem cell transplantation
Phase III

MedlinePlus related topics:  Bone Marrow Diseases;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Induction Chemotherapy Followed By Cytogenetic Risk-Adapted Intensification Therapy Followed By Interleukin-2 Versus No Further Therapy in Patients With Previously Untreated Acute Myeloid Leukemia

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study.

  • Patients are randomized to 1 of 2 treatment arms. (Arm II closed to accrual as of 8/11/03.)
  • Arm I: Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV over 5-10 minutes followed by etoposide IV over 2 hours on days 1-3. Patients with 20% or greater bone marrow cellularity and greater than 5% leukemia blasts at the end of the first course receive a second course of cytarabine IV continuously on days 1-5 and daunorubicin IV over 5-10 minutes followed by etoposide IV over 2 hours on days 1 and 2.
  • Arm II (closed to accrual as of 8/11/03): Patients receive PSC 833 IV continuously on days 1-3 and cytarabine, daunorubicin, and etoposide as in arm I. Patients with 20% or greater bone marrow cellularity and greater than 5% leukemia blasts at the end of the first course receive a second course of PSC 833 IV continuously on days 1 and 2 and cytarabine, daunorubicin, and etoposide as in arm I.
  • Patients in complete remission receive intensification therapy. Therapy begins no earlier than 2 weeks and no later than 4 weeks after complete remission is attained. Patients are stratified according to cytogenetics (favorable [t(8;21)(q22;q22) or inv(16)(p13;q22) or t(16;16)(p13;q22)] vs unfavorable [all other karyotypes]).
  • Favorable: Patients receive high-dose cytarabine (HiDAC) IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats no earlier than 28 days after the prior course and no later than 14 days after hematopoietic recovery for two more courses.
  • Patients are further divided into two groups based on ability to receive peripheral blood stem cell transplantation (PBSCT) (yes vs no).
  • PBSCT group: Patients receive etoposide IV continuously and HiDAC IV over 2 hours every 12 hours on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 14 and continuing until peripheral blood stem cell (PBSC) collection is completed. Patients who are not able to undergo PBSCT after HiDAC/etoposide continue treatment in the non-PBSCT group. At least 4 weeks after HiDAC/etoposide recovery, patients receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 4 hours on day -3 prior to PBSCT. Patients receive autologous PBSC infusion on day 0. Patients also receive G-CSF SC beginning on day 0 and continuing until hematopoietic recovery.
  • Non-PBSCT group: Patients receive etoposide, HiDAC, and G-CSF as in the PBSCT group. After hematopoietic recovery, patients then receive HiDAC IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats no earlier than 28 days after prior course and no later than 14 days after hematopoietic recovery for one more course.
  • Patients are again randomized to 1 of 2 treatment arms.
  • Arm I: Patients begin therapy no later than 120 days after the first day of the last course of HiDAC treatment OR day 0 of PBSCT. Patients receive low-dose interleukin-2 (IL-2) SC on days 1-14, 19-28, 33-42, 47-56, 61-70, and 75-90. In addition, patients receive high-dose IL-2 SC on days 15-17, 29-31, 43-45, 57-59, and 71-73.
  • Arm II: Patients are observed and receive no further therapy. Patients are followed at 1 month, every 2 months for 2 years, every 6 months for 2 years, and then annually for 6 years.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 4 years.

Eligibility

Ages Eligible for Study:  15 Years   -   59 Years,  Genders Eligible for Study:  Both

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

Location and Contact Information


Alabama
      Northeast Alabama Regional Medical Center, Anniston,  Alabama,  36207,  United States; Recruiting
Thomas W. Twele, MD  256-236-2549 

California
      Naval Medical Center - San Diego, San Diego,  California,  92134-3202,  United States; Recruiting
Preston Gable, MD  619-532-7303    pgable@nmcsd.med.navy.mil 

      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States; Recruiting
Stephen L. Seagren, MD  619-543-5303 

      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115,  United States; Recruiting
Alan Paul Venook, MD  800-888-8664    venook@cc.ucsf.edu 

      Veterans Affairs Medical Center - San Diego, San Diego,  California,  92161,  United States; Recruiting
Saeeda Kirmani, MD  619-552-8585 ext. 3356    skirmani@ucsd.edu 

      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States; Recruiting
Patricia A. Cornett, MD  415-221-4810 ext. 3423    patricia.cornett@med.va.gov 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

District of Columbia
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Edward P. Gelmann, MD  202-444-7303    gelmanne@georgetown.edu 

      Veterans Affairs Medical Center - Washington, DC, Washington,  District of Columbia,  20422,  United States; Recruiting
Steven H. Krasnow, MD  202-745-8178    krasnow.steven@washington.va.gov 

      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
Thomas Joseph Reid, MD, PhD, FACP  202-782-5762    thomas.reid@na.amedd.army.mil 

Florida
      Broward General Medical Center, Fort Lauderdale,  Florida,  33316,  United States; Recruiting
Luis Ramon Barreras, MD, FACP  954-771-0692 

      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States; Recruiting
Rogerio C. Lilenbaum, MD  305-674-2625 

      Florida Hospital Cancer Institute, Orlando,  Florida,  32804,  United States; Recruiting
Jane Crofton, RN, BSN, OCN  407-303-2090 

      Memorial Cancer Institute at Memorial Regional Hospital, Hollywood,  Florida,  33021,  United States; Recruiting
Atif M. Hussein, MD  954-986-6363    ahussein@mhs.net 

Illinois
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States; Recruiting
John W. Kugler, MD  309-243-3605 

      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States; Recruiting
Keith L. Shulman, MD  773-564-5022    KShulman@weisshospital.org 

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Karen Wendling  773-834-7424 

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States; Recruiting
Thomas E. Lad, MD  312-996-2046 

      West Suburban Center for Cancer Care, River Forest,  Illinois,  60305,  United States; Recruiting
John L. Showel, MD  708-763-2700    doc.shoj@wsmc.org 

Indiana
      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States; Recruiting
Sreenivasa Rao Nattam, MD  260-484-8830    ledgar@fwmoh.com 

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Gerald H. Clamon, MD  319-356-8110 

Kentucky
      Baptist Hospital East - Louisville, Louisville,  Kentucky,  40207,  United States; Recruiting
Daniel C. Scullin, MD  502-897-1166 

Maryland
      Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore,  Maryland,  21201,  United States; Recruiting
Martin J. Edelman, MD  410-328-2703    medelman@umm.edu 

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
George P. Canellos, MD  617-632-3470    george_canellos@dfci.harvard.edu 

      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01655,  United States; Recruiting
Pankaj Bhargava  508-856-6884    bhargavp@ummhc.org 

Michigan
      Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph,  Michigan,  49085,  United States; Recruiting
Cynthia Bender, BA, CRA  269-985-4516    cbender@lakelandregional.org 

Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Bruce A. Peterson, MD  612-624-5631 

      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Vicki A. Morrison, MD  612-467-4135    morri002@tc.umn.edu 

Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Michael C. Perry, MD  573-882-4979    perrym@health.missouri.edu 

      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
Nancy L. Bartlett, MD  314-362-4843 

      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States; Recruiting
William P. Patterson, MD  573-882-6163 

Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States; Recruiting
Margaret Anne Kessinger, MD  402-559-7511    makessin@unmc.edu 

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
John Allan Ellerton, MD, CM  702-384-0013    k.vanwagenen@sncrf.org 

      Veterans Affairs Medical Center - Las Vegas, Las Vegas,  Nevada,  89106,  United States; Recruiting
Chitha R. Hulugalle, MD  702-696-3000 

New Hampshire
      New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett,  New Hampshire,  03106,  United States; Recruiting
Douglas Jay Weckstein, MD  603-622-6484    d.weckstein@nhoh.com 

      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756-0002,  United States; Recruiting
Marc Stuart Ernstoff, MD  603-650-5534    Marc.S.Ernstoff@Hitchcock.org 

New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103,  United States; Recruiting
Edison Catalano, MD  856-342-2506 

New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Vincent P. Vinciguerra, MD  516-562-8954 

      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse,  New York,  13057,  United States; Recruiting
Jeffrey J. Kirshner, MD  315-472-7504 

      Elmhurst Hospital Center, Elmhurst,  New York,  11373,  United States; Recruiting
Vladimir Benisovich, MD  718-334-3723    beniso@aol.com 

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Clifford A. Hudis, MD  212-639-6483 

      Mount Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
Lewis R. Silverman, MD  212-241-5520    lewis.silverman@mssm.edu 

      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States; Recruiting
Scott Wadler, MD  212-746-2844    scw2004@med.cornell.edu 

      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Daniel R. Budman, MD  516-562-8958 

      Queens Cancer Center of Queens Hospital, Jamaica,  New York,  11432,  United States; Recruiting
Hans W. Grunwald, MD  718-883-4118    hans.grunwald@mssm.edu 

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Ellis G. Levine, MD  716-845-8547 

      SUNY Upstate Medical University Hospital, Syracuse,  New York,  13210,  United States; Recruiting
Stephen L. Graziano, MD  315-464-8200    grazians@upstate.edu 

      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States; Recruiting
Lynn Marie Steinbrenner, MD  716-862-3191    lynn.steinbrenner@med.va.gov 

      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States; Recruiting
Leslie Marion Howard, MD  315-476-7461 ext. 4018    leslie.howard@med.va.gov 

North Carolina
      Cape Fear Valley Medical Center, Fayetteville,  North Carolina,  28302-2000,  United States; Recruiting
Kamal M. Bakri, MD  910-609-6910 

      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
James N. Atkins, MD  336-777-3088 

      Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst,  North Carolina,  28374,  United States; Recruiting
Ellen M. Willard, MD  910-295-9205 

      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
David Duane Hurd, MD  336-716-2088    dhurd@wfubmc.edu 

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Jeffrey Crawford, MD  919-684-5621    crawf006@mc.duke.edu 

      Lenoir Memorial Cancer Center, Kinston,  North Carolina,  28503-1678,  United States; Recruiting
Peter R. Watson, MD  252-559-2200 ext. 201 

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States; Recruiting
Thomas C. Shea, MD  919-966-7746    sheaT@med.unc.edu 

      NorthEast Oncology Associates - Concord, Concord,  North Carolina,  28025,  United States; Recruiting
James Grier Wall, MD  704-783-1370    jwall@northeastmedical.org 

      Veterans Affairs Medical Center - Asheville, Asheville,  North Carolina,  28805-9913,  United States; Recruiting
John C. Lucke, MD  828-299-2540 

      Veterans Affairs Medical Center - Durham, Durham,  North Carolina,  27705,  United States; Recruiting
Michael J. Kelley, MD  919-286-0411 ext. 7326 

      Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington,  North Carolina,  28402-9025,  United States; Recruiting
Cyrus A. Kotwall, MD  910-763-4630 

Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Clara D. Bloomfield, MD  614-293-7518    bloomfield-1@medctr.osu.edu 

Oklahoma
      Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Howard Ozer, MD, PhD  405-271-4022 

Rhode Island
      Miriam Hospital at Lifespan, Providence,  Rhode Island,  02906,  United States; Recruiting
William M. Sikov, MD  401-793-7151    wsikov@lifespan.org 

Texas
      Veterans Affairs Medical Center - Dallas, Dallas,  Texas,  75219,  United States; Recruiting
Jonathan Dowell, MD  214-857-0737 

Vermont
      Green Mountain Oncology Group, Bennington,  Vermont,  05201,  United States; Recruiting
L. Herbert Maurer, MD  802-442-1290    mauh@phin.org 

      Vermont Cancer Center at University of Vermont, Burlington,  Vermont,  05401-3498,  United States; Recruiting
Hyman Bernard Muss, MD  802-847-3827 

Virginia
      Martha Jefferson Hospital, Charlottesville,  Virginia,  22902,  United States; Recruiting
Stefan M. Gorsch, MD  434-982-8410 

      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States; Recruiting
John D. Roberts, MD  804-828-0450 

      Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke,  Virginia,  24014,  United States; Recruiting
Paul D. Richards, MD  540-982-0237    paul.richards@usoncology.com 

      Virginia Oncology Associates - Norfolk, Norfolk,  Virginia,  23502,  United States; Recruiting
Paul R. Conkling, MD  757-466-8683 

West Virginia
      St. Mary's Medical Center, Huntington,  West Virginia,  25701,  United States; Recruiting
Gerrit A. Kimmey, MD  304-528-4645 

Study chairs or principal investigators

Jonathan Eliahu Kolitz, MD,  Study Chair,  North Shore University Hospital   
Richard A. Larson, MD,  University of Chicago Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068234; CALGB-19808; NCT00006363
Record last reviewed:  July 2004
Last Updated:  April 5, 2005
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006363
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005