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Trial record 35 of 170 for:    "Acute Lymphocytic Leukemia" | "Etoposide"

Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002816
Recruitment Status : Completed
First Posted : June 23, 2004
Last Update Posted : August 22, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE June 23, 2004
Last Update Posted Date August 22, 2013
Study Start Date  ICMJE December 1996
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
Event Free Survival
The evaluation of the relationship between prognostic or treatment factors and EFS
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00002816 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia
Official Title  ICMJE EXTRAMEDULLARY RELAPSE AND OCCULT BONE MARROW INVOLVEMENT IN CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA: A PHASE III GROUP-WIDE STUDY
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating children who have relapsed acute lymphoblastic leukemia.

Detailed Description

OBJECTIVES: I. Improve the outcome in children with first isolated central nervous system (CNS), testicular, or ocular relapse of acute lymphoblastic lymphoma (ALL), and increase the knowledge of the characteristics of extramedullary and subsequent relapses of ALL. II. Quantitate, by current molecular biologic techniques, occult systemic leukemia in cases of conventional isolated extramedullary relapse, and examine the relationship between this assessment and subsequent clinical outcome, particularly overt marrow relapse. III. Quantitate occult systemic leukemia in subsets of extramedullary relapse that include site (CNS, testis, or eye), time of relapse (early or late), initial risk group, immunophenotype, DNA index and karyotype, gender (for CNS and eye), and ethnicity, and assess the response to therapy in patients entered on companion protocol CCG-B958. IV. Compare the relative sensitivities of two quantitative in vitro assays for occult systemic leukemia (fluorescence-activated cell sorter/leukemic progenitor cell clonogenic assay vs. polymerase chain reaction-based clonospecific assay), correlate the assays with clinical outcome, and assess other biologic studies of leukemic cells (e.g., neurotropic potential in the SCID mouse xenograft model and methotrexate sensitivity). V. Determine the event-free survival (EFS) and pattern of failure in children with first isolated CNS, testicular, or ocular relapse after treatment that includes intensive systemic chemotherapy. VI. Correlate EFS in patients with CNS and ocular relapse with sex, and in patients with relapse at all three sites with ethnicity. VII. Evaluate the impact of combined chemotherapy and radiotherapy on health status in survivors at two and four years after extramedullary relapse and study entry.

OUTLINE: All patients receive induction chemotherapy over 5 weeks with: etoposide, ifosfamide/mesna, dexamethasone, vincristine, and pegaspargase (if pegaspargase is not available, E. coli asparaginase may be substituted throughout study); then dexamethasone, vincristine, pegaspargase (or E. coli asparaginase), and high-dose methotrexate with leucovorin rescue; and triple intrathecal chemotherapy (TIT). Following induction chemotherapy, all patients receive two 6-week courses of intensification therapy with intermittent TIT; each course consists of dexamethasone, vincristine, high-dose methotrexate/leucovorin, thioguanine, cytarabine, etoposide, and pegaspargase (or E. coli asparaginase) followed by dexamethasone, vincristine, high-dose methotrexate/leucovorin, thioguanine, ifosfamide/mesna, and idarubicin. Patients receive 2 additional courses of intensification chemotherapy followed by four 12-week courses of maintenance chemotherapy with vincristine and methotrexate every 2 weeks and daily oral thioguanine. Total duration of therapy is 78 weeks. Patients with isolated ocular relapse receive local radiotherapy prior to initiation of induction chemotherapy; those who also have CNS leukemia begin TIT with the radiotherapy. Patients with CNS relapse receive craniospinal irradiation during the first month of maintenance therapy, with the dose and fields based on whether they will receive TBI and whether they have had CNS irradiation previously. Patients with testicular relapse receive bilateral testicular irradiation during the first 3 weeks of intensification therapy. Patients are followed every 3 months for 3 years, every 6 months for 3 years, and yearly thereafter, or upon relapse, second malignancy, loss to follow up, or death. All patients undergo quality-of-life assessment at entry and 2 and 4 years after entry.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Leukemia
Intervention  ICMJE
  • Drug: cytarabine
    Given IV
    Other Names:
    • Cytosine Arabinoside
    • Ara-C
    • Cytosar-U
    • NSC-63878
  • Drug: dexamethasone
    Given IV
    Other Names:
    • Decadron
    • NSC- 34521
  • Drug: etoposide
    Given IV
    Other Names:
    • VP-16
    • VePesid
    • NSC-14154p
  • Drug: idarubicin
    Given IV
    Other Names:
    • Idamycin
    • NSC-256439
  • Drug: ifosfamide
    Given IV
    Other Names:
    • Ifex
    • NSC-109724
  • Drug: leucovorin calcium
  • Drug: mesna
    Given IV
    Other Names:
    • Mesnex
    • NSC-113891
  • Drug: pegaspargase
    Given IV
    Other Names:
    • PEG Asparaginase
    • PEG-ASP
    • K/H
    • KYOWA
    • HAKKO
    • NSC-644954
  • Drug: therapeutic hydrocortisone
  • Drug: thioguanine
  • Drug: vincristine sulfate
    Given IV
    Other Names:
    • Oncovin
    • NSC-675574
  • Radiation: low-LET cobalt-60 gamma ray therapy
  • Radiation: low-LET electron therapy
  • Radiation: low-LET photon therapy
  • Drug: Methotrexate
    Given IV
    Other Names:
    • MTX
    • NSC-740
Study Arms  ICMJE
  • Experimental: EARLY # CNS RELAPSE with BM DONOR
    Induction (Etoposide, Ifosfamide with Mesna Uroprotection,Ifosfamide, Dexamethasone, Vincristine sulfate, PEG, ITT (methotrexate, cytosine arabinoside and therapeutic hydrocortisone), and leucovorin calcium then Intensification (4 courses of 6 weeks, ITT, dexamethasone, vincristine, methotrexate, leucovorin, 6-Thioguanine, cytarabine (Ara-C), Etoposide, pegaspargase, Ifosfamide with Mesna) and Idarubicin and CXRT.
    Interventions:
    • Drug: cytarabine
    • Drug: dexamethasone
    • Drug: etoposide
    • Drug: idarubicin
    • Drug: ifosfamide
    • Drug: leucovorin calcium
    • Drug: mesna
    • Drug: pegaspargase
    • Drug: therapeutic hydrocortisone
    • Drug: thioguanine
    • Drug: vincristine sulfate
    • Radiation: low-LET electron therapy
    • Radiation: low-LET photon therapy
    • Drug: Methotrexate
  • Experimental: LATE CNS RELAPSE with/without BM DONOR, TESTICULAR or OCULAR
    Induction (Etoposide, Ifosfamide with Mesna Uroprotection,Ifosfamide, Dexamethasone, Vincristine sulfate, pegaspargase, ITT (methotrexate, cytosine arabinoside and therapeutic hydrocortisone), and leucovorin calcium then Intensification (4 courses of 6 weeks, ITT, dexamethasone, vincristine, methotrexate, leucovorin, 6-Thioguanine, cytarabine (Ara-C), Etoposide, PEG, Ifosfamide with Mesna) and Idarubicin), and Maintenance (4 x 12 courses) of ITT, Vincristine, Methotrexate, T-thioguanine.
    Interventions:
    • Drug: cytarabine
    • Drug: dexamethasone
    • Drug: etoposide
    • Drug: idarubicin
    • Drug: ifosfamide
    • Drug: leucovorin calcium
    • Drug: mesna
    • Drug: pegaspargase
    • Drug: therapeutic hydrocortisone
    • Drug: thioguanine
    • Drug: vincristine sulfate
    • Radiation: low-LET cobalt-60 gamma ray therapy
    • Radiation: low-LET electron therapy
    • Radiation: low-LET photon therapy
    • Drug: Methotrexate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 20, 2007)
120
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Acute lymphoblastic leukemia (ALL) with isolated extramedullary relapse Relapse occurred during or following front-line therapy for ALL Initial diagnosis of more than 25% blasts of L1 or L2 morphology No leukemic marrow (M1) by conventional assessment Patients with B precursor ALL must also be enrolled on study CCG-B958 Relapse occurred in the CNS, testis, or eye Ocular relapse confirmed by an ophthalmologist and by cytology or iris biopsy Combined CNS and ocular relapse eligible Down Syndrome patients not eligible No prior bone marrow transplantation in first remission No prior toxicity from any study drugs Patient age: Under 21

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002816
Other Study ID Numbers  ICMJE 1951
CCG-1951 ( Other Identifier: Children's Cancer Group )
CDR0000064968 ( Other Identifier: Clinical Trials.gov )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Oncology Group
Study Sponsor  ICMJE Children's Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Michael L.N. Willoughby, MD Princess Margaret Hospital for Children
PRS Account Children's Oncology Group
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP