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:||September 2008|
|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 ), 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 with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy.
Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a week, for a total of 12 fractions.
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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||Medical University of South Carolina|
|Study Chair:||Caroline A. Hastings, MD||Children's Hospital & Research Center Oakland|