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

Not Recruiting

Trial ID: NCT00096135


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.

Official Title

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

Stanford Investigator(s)



   - 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

      - 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



   - 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


   - Not specified


   - Not specified


   - 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


   - Shortening fraction ≥ 27% by echocardiogram OR

   - Ejection fraction ≥ 50% by MUGA


   - Not pregnant or nursing


Biologic therapy

   - No prior bone marrow transplantation


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

Endocrine therapy

   - Not specified


   - Not specified


   - Not specified


   - No prior systemic therapy for concurrent extramedullary relapse


drug: cytarabine

drug: daunorubicin hydrochloride

drug: dexamethasone

drug: cyclophosphamide

drug: etoposide

drug: leucovorin calcium

drug: mercaptopurine

drug: methotrexate

drug: pegaspargase

drug: therapeutic hydrocortisone

biological: filgrastim

drug: vincristine sulfate

radiation: radiation therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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