Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • 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

Phase:

N/A

Eligibility


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

Ages Eligible for Study

18 Months - 29 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting