Combination Chemotherapy in Treating Children With Stage III or Stage IV Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia
- Conditions
- LeukemiaLymphoma
- Interventions
- Registration Number
- NCT00003217
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
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.
- Detailed Description
OBJECTIVES: I. Evaluate the feasibility and toxicity of dose intensification of methotrexate and cyclophosphamide in patients with stage III or IV small, noncleaved cell non-Hodgkin's lymphoma or B cell acute lymphoblastic leukemia. II. Estimate the response rate and survival of these patients after this therapy.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment methotrexate See detailed description. Treatment cyclophosphamide See detailed description. Treatment filgrastim See detailed description. Treatment cytarabine See detailed description. Treatment dexamethasone See detailed description. Treatment doxorubicin hydrochloride See detailed description. Treatment vincristine sulfate See detailed description.
- Primary Outcome Measures
Name Time Method Event Free Survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Oklahoma Memorial Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States