Status:
COMPLETED
Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18-29 years
Phase:
NA
Brief 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 co...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse. * De...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00096135
Start Date
November 1 2004
Last Update
March 21 2017
Active Locations (153)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
3
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
4
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205