filgrastim
Biological5 ug/kg/day sub Q injection day 7 until ANC>5000/ul courses II-VII
NCT Number: NCT00039130
RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.
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Notify Me16 year and older
All sexes
Interventional
Phase 2
Naval Medical Center - San Diego, San Diego, California, United States
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia vs lymphoma).
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per stratum) will be accrued for this study within 3 years.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
5 ug/kg/day sub Q injection day 7 until ANC>5000/ul courses II-VII
Day 8 course II 50 mg/sq m IV infusion: d 8 course IV & VI 375mg/sq m IV Day 10 course II: 325 mg/sq m IV infusion Day 12 course II: 375 mg/sq m IV infusion
200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII
1 g/sq m/day IV infusion Days 4 & 5, courses II, IV, VI
10mg/sq m PO or IV Days 1-5 courses II-VII
25 mg/sq m/day IV infusion Days 4 & 5 courses III,V, VII
80 mg/sq m/day IV infusion Days 4 & 5 courses II, IV, VI
800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI
25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX <10nM, courses II-VII
1.5 g/sq m IV infusion Day 1 courses II-VII
60 mg/sq m PO/day Days 1-7 course I
2 mg IV push Day 1 courses II-VII
300 mg/day PO Days 1-14, course I
Time frame: 6 months
Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
Time frame: 2 years
Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure.
Time frame: 2 years
Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
Alliance for Clinical Trials in Oncology
Other
Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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