Combination Chemotherapy in Treating Children With Stage III or Stage IV Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia
NCT ID: NCT00003217
Last Updated: 2014-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
1998-03-31
2006-09-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of methotrexate and cyclophosphamide in treating children who have stage III or stage IV non-Hodgkin's lymphoma or acute lymphoblastic leukemia.
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Detailed Description
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OUTLINE: This is a two-stage study. Patients will receive cytarabine either by continuous infusion (first stage) or bolus injection (second stage). Patients are stratified by disease (stage III non-Hodgkin's lymphoma (NHL) vs stage IV NHL vs stage B acute lymphoblastic leukemia). Therapy for all patients consists of alternating courses of "A" and "B". Patients with stage III disease receive 4 courses of chemotherapy (ABAB) while those with stage IV disease and B cell acute lymphoblastic leukemia receive 6 chemotherapy courses (ABABAB). Course A - Induction: Patients receive intrathecal methotrexate (IT MTX) and intrathecal cytarabine (IT Ara-C) on days 1, 4, and 11. Dexamethasone is administered by IV or orally twice a day on days 1-5. Cyclophosphamide IV is administered every 12 hours on days 1-3. Doxorubicin IV is administered over 15 minutes beginning 12 hours after the beginning of the 6th dose of cyclophosphamide (day 4). At the same time, vincristine IV is administered, then repeated on day 11. Patients begin filgrastim (granulocyte colony-stimulating factor; G-CSF) subcutaneously or IV over 30 minutes on day 5. Course B - Induction: The first 10 patients enrolled receive cytarabine by continuous infusion while the second 10 patients enrolled receive cytarabine by bolus IV. Patients begin treatment on day 18 and receive methotrexate IV over 24 hours plus IT MTX during hour 1. Dexamethasone is administered by IV or orally twice a day on days 1-5. After completing the 24 hour IV MTX infusion, patients begin cytarabine by continuous infusion over 48 hours or bolus IV every 12 hours for 4 doses. Patients receive G-CSF subcutaneously or IV over 30 minutes beginning on day 22. Patients are assessed for remission status before day 36. Course A - Consolidation: Patients receive dexamethasone IV or orally twice a day on days 1-5. IT MTX and IT Ara-C are administered on days 1 and 4. Cyclophosphamide is administered as during Induction, with vincristine IV and doxorubicin IV over 15 minutes 12 hours later. Vincristine repeats 1 week later. G-CSF administration begins on day 5. Course B - Consolidation: Therapy begins on day 22 with dexamethasone administered as previously. Methotrexate infusion and IT MTX are administered as in Course B - Induction, as is cytarabine (either as a continuous infusion or bolus IV). G-CSF is also administered as previously. Patients are followed monthly for the first 6 months, every 2 months for the next 6 months, then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 16 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
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filgrastim
cyclophosphamide
cytarabine
dexamethasone
doxorubicin hydrochloride
methotrexate
vincristine sulfate
Interventions
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filgrastim
cyclophosphamide
cytarabine
dexamethasone
doxorubicin hydrochloride
methotrexate
vincristine sulfate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV antibody positive allowed Not pregnant or lactating
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior emergency steroid therapy may be allowed Radiotherapy: Prior emergency radiotherapy may be allowed Surgery: Prior surgery allowed Other: No concurrent dexamethasone as an anti-emetic
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Timothy C. Griffin, MD
Role: STUDY_CHAIR
Cook Children's Medical Center - Fort Worth
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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POG-9517
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000066078
Identifier Type: OTHER
Identifier Source: secondary_id
9517
Identifier Type: -
Identifier Source: org_study_id
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