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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Asparaginase; BB 1101; Calcium, Dietary; Cortisol succinate; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Lenograstim; Leucovorin; Levoleucovorin; Mercaptopurine; Methotrexate; Pegaspargase; Vincristine

Criteria

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