Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

February 14, 2017 updated by: Children's Oncology Group

Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OBJECTIVES:

Primary

  • Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse.
  • Determine the efficacy of intensive systemic chemotherapy without testicular radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular relapse.
  • Determine the toxicity of these regimens in these patients.

Secondary

  • Determine whether bone marrow involvement is present at the time of extramedullary relapse in patients treated with these regimens.
  • Correlate pretreatment minimal residual disease with outcomes in patients treated with these regimens.
  • Correlate the role of host gene polymorphisms with toxicity of these regimens and incidence and outcome in these patients.
  • Determine the neuropsychological sequelae associated with isolated CNS relapse and these treatment regimens in these patients.

OUTLINE: This is a pilot, multicenter study. All patients receive common induction, consolidation, re-induction, and intensification chemotherapy. Patients are stratified to maintenance therapy according to site of extramedullary relapse (CNS vs testicular).

  • Induction therapy (weeks 1-4): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-28; daunorubicin* IV over 15 minutes on days 1, 8, and 15; and intrathecal triple therapy** (ITT) comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, 15, and 22.

NOTE: *The total dose of anthracyclines on this study is capped at 450 mg/m2. Once this dose is reached, all subsequent doses of daunorubicin are omitted.

NOTE: **Patients with isolated testicular relapse receive ITT on day 1 only.

In addition to the above, patients with isolated testicular relapse also receive high-dose methotrexate IV continuously over 24 hours on day -14. Patients with clinical signs of disease at the end of induction undergo testicular biopsy.

Patients with CNS disease who do not achieve CNS remission after induction therapy receive additional ITT as above on days 29 and 36.

  • Consolidation therapy (weeks 5-10): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly (IM) on days 2 and 23. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on days 3 and 24 and continuing until blood counts recover.

Patients with isolated testicular relapse with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy.

  • Intensification I (weeks 11-22): Patients receive high-dose methotrexate with leucovorin calcium rescue IV over 24 hours on days 1, 22, 43, and 64 and oral mercaptopurine once daily on days 2-6, 23-27, 44-48, and 65-69. Patients also receive etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 8, 29, 50, and 71. Patients receive ITT* on days 15, 36, 57, and 78.

NOTE: *Patients with isolated testicular relapse receive ITT on days 36 and 78 only.

  • Reinduction therapy (weeks 23-26): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-7 and 15-21, and daunorubicin IV over 15 minutes on days 1, 8, and 15.
  • Intensification II (weeks 27-50): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2, 43-44, 85-86, and 127-128; pegaspargase IM on days 2, 44, 86, and 128; ITT* on days 22, 64, 106, and 148; high-dose methotrexate IV continuously over 24 hours on days 29, 71, 113, and 155; oral mercaptopurine on days 30-34, 72-76, 114-118, and 156-160; and etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 36, 78, 120, and 162. Patients also receive G-CSF SC beginning on days 3, 45, 87, and 129 and continuing until blood counts recover.

NOTE: *Patients with isolated testicular relapse receive ITT on days 22 and 106 only.

  • Chemotherapy and radiotherapy (weeks 51-54): Patients receive oral dexamethasone twice daily on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, and pegaspargase IM on days 1 and 15.

Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a week, for a total of 12 fractions.

  • Maintenance therapy for isolated CNS relapse: (weeks 55-104): Patients receive dexamethasone PO orIV twice daily on days 1-5; oral mercaptopurine once daily on days 1-42; methotrexate IM on days 1, 8, 15, 22, 29, and 36; and vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 10 weeks for 5 courses.

  • Maintenance therapy for isolated testicular relapse:

    • (Weeks 55-74): Patients receive ITT on day 1 and dexamethasone, mercaptopurine, methotrexate, vincristine, and cyclophosphamide as in maintenance therapy for isolated CNS relapse. Treatment repeats every 10 weeks for 2 courses.
    • (Weeks 75-106): Patients receive vincristine IV on day 1; dexamethasone orally or IV on days 1-5; oral mercaptopurine on days 1-28; and methotrexate IM on days 1, 8, 15, and 22. Treatment repeats every 28 days for 8 courses. Patients also receive ITT on day 1 every 12 weeks for 3 doses.

Patients with combined testicular and CNS relapse receive high-dose methotrexate IV continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy administered during the induction, consolidation, intensification I, reinduction, intensification II, and maintenance phases of therapy as isolated CNS relapse patients.

All patients undergo neuropsychological assessment within 3 months after completion of induction therapy (before cranial radiotherapy) and at 2 years after completion of treatment.

Patients are followed for survival.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3G9
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Hôpital Sainte Justine
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
  • New Zealand
      • Auckland, New Zealand, 1
        • Starship Children's Health
      • Christchurch, New Zealand, 8140
        • Christchurch Hospital
  • Switzerland
      • Bern, Switzerland, 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Switzerland, 1205
        • Swiss Pediatric Oncology Group Geneva
      • Lausanne, Switzerland, 1011
        • Swiss Pediatric Oncology Group Lausanne
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Phoenix Children's Hospital
      • Tucson, Arizona, United States, 85724-5024
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, United States, 90027
        • Southern California Permanente Medical Group
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, United States, 90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, United States, 90027
        • Childrens Hospital Los Angeles
      • Madera, California, United States, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, United States, 94609
        • Children's Hospital and Research Center Oakland
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, United States, 95798
        • Lucile Packard Children's Hospital at Stanford University Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Cancer Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Medical Center - Oakland
      • San Francisco, California, United States, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Center for Cancer and Blood Disorders
      • Denver, Colorado, United States, 80218
        • Presbyterian - St. Luke's Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center Cancer Center
      • Fort Myers, Florida, United States, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville, Florida, United States, 32610-0232
        • University of Florida Shands Cancer Center
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital
      • Miami, Florida, United States, 33176
        • Baptist-South Miami Regional Cancer Program
      • Orlando, Florida, United States, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Orlando, Florida, United States, 32806
        • Nemours Children's Clinic - Orlando
      • Orlando, Florida, United States, 32806
        • M.D. Anderson Cancer Center at Orlando
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Saint Petersburg, Florida, United States, 33701
        • All Children's Hospital
      • Tampa, Florida, United States, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, United States, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii
    • Idaho
      • Boise, Idaho, United States, 83712-6297
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612-7243
        • University of Illinois Cancer Center
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Oak Lawn, Illinois, United States, 60453
        • Keyser Family Cancer Center at Advocate Hope Children's Hospital
      • Park Ridge, Illinois, United States, 60068-1174
        • Advocate Lutheran General Cancer Care Center
      • Springfield, Illinois, United States, 62794-9677
        • Simmons Cooper Cancer Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis Hospital
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, United States, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
      • Louisville, Kentucky, United States, 40232
        • Kosair Children's Hospital
    • Maine
      • Bangor, Maine, United States, 04401
        • CancerCare of Maine at Eastern Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Floating Hospital for Children at Tufts - New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0286
        • C.S. Mott Children's Hospital at University of Michigan Medical Center
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503-2560
        • Butterworth Hospital at Spectrum Health
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Kalamazoo, Michigan, United States, 49007-5381
        • CCOP - Kalamazoo
      • Lansing, Michigan, United States, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Cancer Clinic
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89109-2306
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center Cancer Center
      • Morristown, New Jersey, United States, 07962
        • Overlook Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5636
        • University of New Mexico Cancer Center
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, United States, 11201-5493
        • Brooklyn Hospital Center
      • Brooklyn, New York, United States, 11219
        • Maimonides Cancer Center at Maimonides Medical Center
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11040
        • Schneider Children's Hospital
      • New York, New York, United States, 10016
        • NYU Cancer Institute at New York University Medical Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794-9446
        • Stony Brook University Cancer Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Akron Children's Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106-5000
        • Rainbow Babies and Children's Hospital
      • Columbus, Ohio, United States, 43205-2696
        • Nationwide Children's Hospital
      • Dayton, Ohio, United States, 45404-1815
        • Dayton Children's - Dayton
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio Cancer Center
      • Youngstown, Ohio, United States, 44501
        • Tod Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Knight Cancer Institute at Oregon Health and Science University
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Hospital and Health Center and Children's Hospital
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, United States, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, United States, 19134-1095
        • St. Christopher's Hospital for Children
      • Philadelphia, Pennsylvania, United States, 19104-9786
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh of UPMC
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • T.C. Thompson Children's Hospital
      • Knoxville, Tennessee, United States, 37901
        • East Tennessee Children's Hospital
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Tech University Health Sciences Center School of Medicine - Amarillo
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center - Fort Worth
      • Houston, Texas, United States, 77030-2399
        • Baylor University Medical Center - Houston
      • San Antonio, Texas, United States, 78229-3993
        • Methodist Children's Hospital of South Texas
      • San Antonio, Texas, United States, 78207
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84113-1100
        • Primary Children's Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Falls Church, Virginia, United States, 22042-3300
        • INOVA Fairfax Hospital
      • Roanoke, Virginia, United States, 24014
        • Carilion Medical Center for Children at Roanoke Community Hospital
    • Washington
      • Spokane, Washington, United States, 99220-2555
        • Providence Cancer Center at Sacred Heart Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • West Virginia University Health Sciences Center - Charleston
      • Morgantown, West Virginia, United States, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Center for Cancer and Blood
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, United States, 53226
        • Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL)

    • B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)
    • In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis

  • First isolated CNS and/or testicular relapse

    • Isolated CNS relapse, as defined by 1 of the following:

      • WBC ≥ 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin

      • Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:

        • Identifiable blasts AND 1 of the following:

          • B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart)
          • T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart) (Closed to accrual as of 05/20/10)
    • Isolated testicular relapse, defined as biopsy proven testicular involvement
  • No Down syndrome
  • No T-cell ALL or T-cell non-Hodgkin lymphoma
  • No known optic nerve and/or retinal involvement

PATIENT CHARACTERISTICS:

Age

  • 18 months to 29 years at relapse

Performance status

  • Karnofsky 30-100% (for patients > 16 years of age) OR
  • Lansky 30-100% (for patients ≤ 16 years of age)

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine adjusted according to age as follows:

    • No greater than 0.4 mg/dL (≤ 5 months)
    • No greater than 0.5 mg/dL (6 months -11 months)
    • No greater than 0.6 mg/dL (1 year-23 months)
    • No greater than 0.8 mg/dL (2 years-5 years)
    • No greater than 1.0 mg/dL (6 years-9 years)
    • No greater than 1.2 mg/dL (10 years-12 years)
    • No greater than 1.4 mg/dL (13 years and over [female])
    • No greater than 1.5 mg/dL (13 years to 15 years [male])
    • No greater than 1.7 mg/dL (16 years and over [male]) OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular

  • Shortening fraction ≥ 27% by echocardiogram OR
  • Ejection fraction ≥ 50% by MUGA

Other

  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior bone marrow transplantation

Chemotherapy

  • Prior total anthracycline dosage ≤ 360 mg/m^2

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior systemic therapy for concurrent extramedullary relapse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CNS Patients-Treatment (combination chemotherapy)
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
given IV
Other Names:
  • VCR
  • Oncovin
  • LCR
  • NSC #67574
Biological: filgrastim
given subcutaneously (SC)
Other Names:
  • G-CSF
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • Neupogen
  • NSC 614629
Drug: cyclophosphamide
IV over 15-30 minutes
Other Names:
  • CYTOXAN
  • NSC #26271
Drug: cytarabine
IV over 3 hours twice daily
Other Names:
  • Ara-C
  • Cytosar
  • Cytosine arabinoside
  • NSC #6387
Drug: daunorubicin hydrochloride
IV over 15 minutes
Other Names:
  • Cerubidine
  • NSC #82151
  • Daunomycin
  • rubidomycin
Drug: dexamethasone
oral twice daily
Other Names:
  • Decadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Drug: etoposide
IV over 1 hour
Other Names:
  • VP-16
  • Etopophos
  • VePesid
  • NSC #141540
Drug: leucovorin calcium
rescue IV over 24 hours
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC 03590
Drug: mercaptopurine
oral
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
  • 6-mercaptopurine
Drug: methotrexate
intramuscularly (IM)
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • Trexall
Drug: pegaspargase
intramuscularly (IM)
Other Names:
  • Oncaspar
  • PEGLA
  • PEG-L-asparaginase
  • PEG-asparaginase
  • polyethylene glycol-L-asparaginase
  • NSC 624239
Radiation: radiation therapy
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.
Experimental: Testicular Relapse Patients (Combination chemotherapy)
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
given IV
Other Names:
  • VCR
  • Oncovin
  • LCR
  • NSC #67574
Biological: filgrastim
given subcutaneously (SC)
Other Names:
  • G-CSF
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • Neupogen
  • NSC 614629
Drug: cyclophosphamide
IV over 15-30 minutes
Other Names:
  • CYTOXAN
  • NSC #26271
Drug: cytarabine
IV over 3 hours twice daily
Other Names:
  • Ara-C
  • Cytosar
  • Cytosine arabinoside
  • NSC #6387
Drug: daunorubicin hydrochloride
IV over 15 minutes
Other Names:
  • Cerubidine
  • NSC #82151
  • Daunomycin
  • rubidomycin
Drug: dexamethasone
oral twice daily
Other Names:
  • Decadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Drug: etoposide
IV over 1 hour
Other Names:
  • VP-16
  • Etopophos
  • VePesid
  • NSC #141540
Drug: leucovorin calcium
rescue IV over 24 hours
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC 03590
Drug: mercaptopurine
oral
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
  • 6-mercaptopurine
Drug: methotrexate
intramuscularly (IM)
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • Trexall
Drug: pegaspargase
intramuscularly (IM)
Other Names:
  • Oncaspar
  • PEGLA
  • PEG-L-asparaginase
  • PEG-asparaginase
  • polyethylene glycol-L-asparaginase
  • NSC 624239
Radiation: radiation therapy
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Event-free Survival
Time Frame: 3 years
Monitoring of efficacy results will be performed in comparison with historical results.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Julio C. Barredo, MD, University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Study Chair: Caroline A. Hastings, MD, UCSF Benioff Children's Hospital Oakland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2004

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AALL02P2
  • COG-AALL02P2 (Other Identifier: Children's Oncology Group)
  • NCI-2011-01623 (Other Identifier: NCI Trial Identifier)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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