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Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradiation (NCT00003700)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia.
  • Biological: G-CSF
    Courses I, II, IV, V: 5 ug/kg/d subQ injection Day 4 until ANC > 5,000 uL after nadir: 7 day minimum for Courses I & IV
    • filgrastim
  • Drug: asparaginase
    6000 U/sq m subQ or IM injection 2X/wk for 6 doses starting on Day 5: Courses I & IV
    • Drug: cyclophosphamide
      1200 mg/sq m IV infusion over 15-30 min Day 1 Courses I & IV (pts < 60y/o) 1000 mg/sq m IV infusion over 15-30 min Day 1 Courses II & V
      • Drug: cytarabine
        2000 mg/sq m IV infusion over 3 hrs Days 1,2, & 3: Courses II & V
        • ara-C
      • Drug: daunorubicin hydrochloride
        80mg/sq m (pts<60y/o)OR 60mg/sq m (pts =/>60y/o) IV infusion over 5-10 min Days 1,2,& 3: Courses I & IV
        • Drug: leucovorin calcium
          Courses III & VI: 25mg/sq m IV infusion Days 2, 9, and 16 5mg/sq m PO q 6 hr for 8 doses or until serum MTX <0.05 uM after ea IV dose
          • Drug: mercaptopurine
            60mg/sq m/d PO every day Course VII
            • Drug: methotrexate
              15mg intrathecal Day 1 Courses II & V 1000mg/sq m IV infusion over 3 hrs Days 1, 8, & 15 and 25mg/sq m PO q 6hr x 4 doses after ea IV dose: Courses III & VI.
              • Drug: prednisone
                60mg/sq m/day PO Days 1-21 (pts<60y/o) OR Days 1-7 (pts >/= 60y/o) Courses I & IV and Days 1-5 of ea 4 cycle in Course VII
                • Drug: vincristine sulfate
                  2 mg total IV infusion Days 1,8,15,& 22 Courses I & IV and Days 1, 8, & 15 Courses III & VI, and Day 1 of ea 4 wk cycle in Course VII
                  • Drug: Allopurinol
                    300mg PO q day Days 1-14 Course I
                    Ages eligible for Study
                    15 Years and older
                    Genders eligible for Study
                    All
                    Accepts Healthy Volunteers
                    No
                    OBJECTIVES:

                    - Determine the complete response rate and toxicity of escalating doses of daunorubicin in patients under 60 years old with untreated acute lymphoblastic leukemia (ALL).

                    - Determine the complete response rate and toxicity of a constant dose of daunorubicin in patients at least 60 years old with untreated ALL.

                    - Determine the toxicity of high dose cytarabine during postremission therapy in these patients.

                    - Determine the CNS relapse rate of ALL when prophylactic intrathecal methotrexate and high-dose intravenous chemotherapy replace cranial irradiation.

                    OUTLINE:

                    - Course I: Patients are assigned to 1 of 2 induction treatment groups based on age.

                    - Group 1 (under age 60): Patients receive cyclophosphamide IV over 15-30 minutes on day 1, escalating doses of daunorubicin IV over 5-10 minutes on days 1-3, vincristine IV on days 1, 8, 15, and 22, oral prednisone on days 1-21, asparaginase intramuscularly on days 5, 8, 11, 15, 18, and 22, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing for at least 7 days and then until blood counts recover.

                    - Group 2 (age 60 and over): Patients receive vincristine, asparaginase, cyclophosphamide, and G-CSF as in group 1, fixed dose daunorubicin IV over 5-10 minutes on days 1-3, and oral prednisone on days 1-7.

                    Patients are then evaluated for bone marrow cellularity on day 29. Those with M0, M1, or M2 cellularity proceed to course II. Patients with M3 cellularity may proceed to course II or be removed from study.

                    - Course II (early intensification): Patients receive intrathecal methotrexate and cyclophosphamide IV over 15-30 minutes on day 1, cytarabine IV over 3 hours on days 1-3, and G-CSF SC beginning on day 4.

                    Bone marrow is again examined on day 29. Patients with M0 or M1 cellularity after course I and no sign of relapse after course II proceed to course III. Patients with M2 or M3 cellularity after course I must have M0 or M1 cellularity after course II to proceed to course III. Patients with M2 or M3 cellularity after course II are removed from study.

                    - Course III: Patients receive intrathecal methotrexate, vincristine IV, and methotrexate IV over 3 hours on days 1, 8, and 15 and oral methotrexate every 6 hours for 4 doses beginning 6 hours after starting methotrexate IV on days 1, 2, 8, 9, 15, and 16. Patients receive leucovorin calcium IV 6 hours after the last oral methotrexate dose on days 2, 9, and 16 and oral leucovorin calcium beginning 12 hours after leucovorin calcium IV for at least 4 doses on days 3, 4, 10, 11, 17, and 18.

                    Patients must be off leucovorin calcium for a minimum of 3 days before beginning days 8 and 15 of treatment. Patients who maintain M0 or M1 cellularity on day 29 of course III continue therapy. Those with M2 or M3 cellularity after course III are removed from the study.

                    - Course IV (Late intensification): Repeat course I.

                    - Course V (Late intensification): Repeat course II.

                    - Course VI (CNS intensification): Repeat course III.

                    - Course VII (Prolonged maintenance): Patients receive oral mercaptopurine daily, vincristine IV once every 4 weeks, oral prednisone on days 1-5, and oral methotrexate on days 1, 8, 15, and 22. Courses repeat every 4 weeks for up to 18 months.

                    Patients with testicular disease receive gonadal radiotherapy anytime after course I. Chemotherapy is not halted during radiotherapy.

                    Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for 10 years.

                    PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study within 15 months.

                    50 locations

                    United States (50)
                    • Veterans Affairs Medical Center - Birmingham
                      Not specified
                      Birmingham, Alabama, United States, 35233
                    • University of California San Diego Cancer Center
                      Not specified
                      La Jolla, California, United States, 92093-0658
                    • UCSF Cancer Center and Cancer Research Institute
                      Not specified
                      San Francisco, California, United States, 94115-0128
                    • Veterans Affairs Medical Center - San Francisco
                      Not specified
                      San Francisco, California, United States, 94121
                    • CCOP - Christiana Care Health Services
                      Not specified
                      Wilmington, Delaware, United States, 19899
                    • Lombardi Cancer Center, Georgetown University
                      Not specified
                      Washington, District of Columbia, United States, 20007
                    • Walter Reed Army Medical Center
                      Not specified
                      Washington, District of Columbia, United States, 20307-5000
                    • CCOP - Mount Sinai Medical Center
                      Not specified
                      Miami Beach, Florida, United States, 33140
                    • University of Illinois at Chicago Health Sciences Center
                      Not specified
                      Chicago, Illinois, United States, 60612
                    • Veterans Affairs Medical Center - Chicago (Westside Hospital)
                      Not specified
                      Chicago, Illinois, United States, 60612
                    • University of Chicago Cancer Research Center
                      Not specified
                      Chicago, Illinois, United States, 60637
                    • University of Iowa Hospitals and Clinics
                      Not specified
                      Iowa City, Iowa, United States, 52242
                    • Veterans Affairs Medical Center - Togus
                      Not specified
                      Togus, Maine, United States, 04330
                    • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
                      Not specified
                      Baltimore, Maryland, United States, 21201
                    • Dana-Farber Cancer Institute
                      Not specified
                      Boston, Massachusetts, United States, 02115
                    • University of Massachusetts Memorial Medical Center
                      Not specified
                      Worcester, Massachusetts, United States, 01655
                    • Veterans Affairs Medical Center - Minneapolis
                      Not specified
                      Minneapolis, Minnesota, United States, 55417
                    • Veterans Affairs Medical Center - Columbia (Truman Memorial)
                      Not specified
                      Columbia, Missouri, United States, 65201
                    • Ellis Fischel Cancer Center - Columbia
                      Not specified
                      Columbia, Missouri, United States, 65203
                    • Barnes-Jewish Hospital
                      Not specified
                      Saint Louis, Missouri, United States, 63110
                    • University of Nebraska Medical Center
                      Not specified
                      Omaha, Nebraska, United States, 68198-3330
                    • CCOP - Southern Nevada Cancer Research Foundation
                      Not specified
                      Las Vegas, Nevada, United States, 89106
                    • Norris Cotton Cancer Center
                      Not specified
                      Lebanon, New Hampshire, United States, 03756
                    • Cooper Cancer Institute
                      Not specified
                      Camden, New Jersey, United States, 08103
                    • St. Barnabas Medical Center
                      Not specified
                      Livingston, New Jersey, United States, 07039
                    • St. Joseph's Hospital and Medical Center
                      Not specified
                      Paterson, New Jersey, United States, 07503
                    • Veterans Affairs Medical Center - Buffalo
                      Not specified
                      Buffalo, New York, United States, 14215
                    • Roswell Park Cancer Institute
                      Not specified
                      Buffalo, New York, United States, 14263-0001
                    • CCOP - North Shore University Hospital
                      Not specified
                      Manhasset, New York, United States, 11030
                    • North Shore University Hospital
                      Not specified
                      Manhasset, New York, United States, 11030
                    • Memorial Sloan-Kettering Cancer Center
                      Not specified
                      New York, New York, United States, 10021
                    • New York Presbyterian Hospital - Cornell Campus
                      Not specified
                      New York, New York, United States, 10021
                    • Mount Sinai Medical Center, NY
                      Not specified
                      New York, New York, United States, 10029
                    • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
                      Not specified
                      Syracuse, New York, United States, 13210
                    • State University of New York - Upstate Medical University
                      Not specified
                      Syracuse, New York, United States, 13210
                    • Veterans Affairs Medical Center - Syracuse
                      Not specified
                      Syracuse, New York, United States, 13210
                    • Lineberger Comprehensive Cancer Center, UNC
                      Not specified
                      Chapel Hill, North Carolina, United States, 27599-7295
                    • Veterans Affairs Medical Center - Durham
                      Not specified
                      Durham, North Carolina, United States, 27705
                    • Duke Comprehensive Cancer Center
                      Not specified
                      Durham, North Carolina, United States, 27710
                    • CCOP - Southeast Cancer Control Consortium
                      Not specified
                      Winston-Salem, North Carolina, United States, 27104-4241
                    • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
                      Not specified
                      Winston-Salem, North Carolina, United States, 27157-1082
                    • Arthur G. James Cancer Hospital - Ohio State University
                      Not specified
                      Columbus, Ohio, United States, 43210
                    • Rhode Island Hospital
                      Not specified
                      Providence, Rhode Island, United States, 02903
                    • Medical University of South Carolina
                      Not specified
                      Charleston, South Carolina, United States, 29425-0721
                    • University of Tennessee, Memphis Cancer Center
                      Not specified
                      Memphis, Tennessee, United States, 38103
                    • Veterans Affairs Medical Center - Memphis
                      Not specified
                      Memphis, Tennessee, United States, 38104
                    • Vermont Cancer Center
                      Not specified
                      Burlington, Vermont, United States, 05401-3498
                    • Veterans Affairs Medical Center - White River Junction
                      Not specified
                      White River Junction, Vermont, United States, 05009
                    • Veterans Affairs Medical Center - Richmond
                      Not specified
                      Richmond, Virginia, United States, 23249
                    • MBCCOP - Massey Cancer Center
                      Not specified
                      Richmond, Virginia, United States, 23298-0037
                    Status:
                    completed
                    Type:
                    Interventional
                    Phase:
                    Start:
                    31 December, 1998
                    Updated:
                    30 June, 2016
                    Participants:
                    163
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