Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
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.
Drug: daunorubicin hydrochloride
Drug: leucovorin calcium
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)|
- Event-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]Monitoring of efficacy results will be performed in comparison with historical results.
- Toxicity graded using the NCI CTCAE version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]Tabulated and analyzed using descriptive statistics.
|Study Start Date:||November 2004|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (combination chemotherapy)
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy for testicular patients only), re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT (see above). Patients are stratified to maintenance therapy according to site of extramedullary relapse (CNS vs testicular).
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
Other Names:Drug: methotrexate
Other Names:Drug: pegaspargase
Other Names:Drug: therapeutic hydrocortisone Drug: vincristine sulfate
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00096135
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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||Children's Hospital & Research Center Oakland|