NCT00096135

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

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT00096135

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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.

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

Disease(s) and\or Condition(s)

Leukemia

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: filgrastim
- Description: given subcutaneously (SC)
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: cyclophosphamide
- Description: IV over 15-30 minutes
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: cytarabine
- Description: IV over 3 hours twice daily
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: daunorubicin hydrochloride
- Description: IV over 15 minutes
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: dexamethasone
- Description: oral twice daily
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: etoposide
- Description: IV over 1 hour
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: leucovorin calcium
- Description: rescue IV over 24 hours
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: mercaptopurine
- Description: oral
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: methotrexate
- Description: intramuscularly (IM)
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: pegaspargase
- Description: intramuscularly (IM)
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: therapeutic hydrocortisone
- Description:
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: DRUG
- Name: vincristine sulfate
- Description: given IV
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)
- Type: RADIATION
- Name: radiation therapy
- Description: 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.
- Arm Group Labels: CNS Patients-Treatment (combination chemotherapy), Testicular Relapse Patients (Combination chemotherapy)

Sponsor

Children's Oncology Group