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

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ClinicalTrials.gov Identifier: NCT00096135
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : August 6, 2015
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: therapeutic hydrocortisone Drug: vincristine sulfate Radiation: radiation therapy Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)
Study Start Date : November 2004
Actual Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: filgrastim
given subcutaneously (SC)
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-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:
  • Cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #6387

Drug: daunorubicin hydrochloride
IV over 15 minutes
Other Names:
  • Daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151

Drug: dexamethasone
oral twice daily
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521

Drug: etoposide
IV over 1 hour
Other Names:
  • VePesid
  • Etopophos
  • VP-16
  • 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
  • 6-mercaptopurine
  • NSC #000755

Drug: methotrexate
intramuscularly (IM)
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #000740

Drug: pegaspargase
intramuscularly (IM)
Other Names:
  • PEG-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239

Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574

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.
 Biological: filgrastim
given subcutaneously (SC)
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-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:
  • Cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #6387

Drug: daunorubicin hydrochloride
IV over 15 minutes
Other Names:
  • Daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151

Drug: dexamethasone
oral twice daily
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521

Drug: etoposide
IV over 1 hour
Other Names:
  • VePesid
  • Etopophos
  • VP-16
  • 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
  • 6-mercaptopurine
  • NSC #000755

Drug: methotrexate
intramuscularly (IM)
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #000740

Drug: pegaspargase
intramuscularly (IM)
Other Names:
  • PEG-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239

Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574

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.


Outcome Measures
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Primary Outcome Measures :
  1. Event-free Survival [ Time Frame: 3 years ]
    Monitoring of efficacy results will be performed in comparison with historical results.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Months to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096135


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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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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
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00096135     History of Changes
Other Study ID Numbers: AALL02P2
COG-AALL02P2 ( Other Identifier: Children's Oncology Group )
NCI-2011-01623 ( Other Identifier: NCI Trial Identifier )
First Posted: November 9, 2004    Key Record Dates
Results First Posted: August 6, 2015
Last Update Posted: March 21, 2017
Last Verified: February 2017
Keywords provided by Children's Oncology Group:
recurrent childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
TdT positive childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Calcium, Dietary
Cytarabine
Dexamethasone
Dexamethasone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
 Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cyclophosphamide
Methotrexate
Etoposide
Etoposide phosphate
Vincristine
Daunorubicin
Asparaginase
Mercaptopurine
Pegaspargase
BB 1101
Lenograstim
Calcium
Levoleucovorin