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
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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 |

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 |

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.
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Biological: filgrastim
given subcutaneously (SC)
Other Names:
Drug: cyclophosphamide IV over 15-30 minutes
Other Names:
Drug: cytarabine IV over 3 hours twice daily
Other Names:
Drug: daunorubicin hydrochloride IV over 15 minutes
Other Names:
Drug: dexamethasone oral twice daily
Other Names:
Drug: etoposide IV over 1 hour
Other Names:
Drug: leucovorin calcium rescue IV over 24 hours
Other Names:
Drug: mercaptopurine oral
Other Names:
Drug: methotrexate intramuscularly (IM)
Other Names:
Drug: pegaspargase intramuscularly (IM)
Other Names:
Drug: therapeutic hydrocortisone Drug: vincristine sulfate given IV
Other Names:
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:
Drug: cyclophosphamide IV over 15-30 minutes
Other Names:
Drug: cytarabine IV over 3 hours twice daily
Other Names:
Drug: daunorubicin hydrochloride IV over 15 minutes
Other Names:
Drug: dexamethasone oral twice daily
Other Names:
Drug: etoposide IV over 1 hour
Other Names:
Drug: leucovorin calcium rescue IV over 24 hours
Other Names:
Drug: mercaptopurine oral
Other Names:
Drug: methotrexate intramuscularly (IM)
Other Names:
Drug: pegaspargase intramuscularly (IM)
Other Names:
Drug: therapeutic hydrocortisone Drug: vincristine sulfate given IV
Other Names:
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. |
- Event-free Survival [ Time Frame: 3 years ]Monitoring of efficacy results will be performed in comparison with historical results.

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Ages Eligible for Study: | 18 Months to 29 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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First isolated CNS and/or testicular relapse
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Isolated CNS relapse, as defined by 1 of the following:
- WBC ≥ 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin
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Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:
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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)
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- Isolated testicular relapse, defined as biopsy proven testicular involvement
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- 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
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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

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

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 |
Responsible Party: | Children's Oncology Group |
ClinicalTrials.gov Identifier: | NCT00096135 |
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 |
recurrent childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia TdT positive childhood acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leucovorin Cytarabine Dexamethasone Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate |
Hydrocortisone hemisuccinate Cyclophosphamide Methotrexate Etoposide Vincristine Daunorubicin Asparaginase Mercaptopurine Pegaspargase Lenograstim Levoleucovorin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |