Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Lymphoma, Leukemia |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 16 - Any |
Updated: | 4/21/2016 |
Start Date: | May 2002 |
End Date: | October 2014 |
Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia
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.
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.
OBJECTIVES:
- Determine the complete response rate in patients with previously untreated Burkitt's
lymphoma or Burkitt's leukemia treated with rituximab and high-intensity chemotherapy
with filgrastim (G-CSF) support.
- Determine the progression-free and overall survival of patients treated with this
regimen.
- Determine the feasibility and toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia
vs lymphoma).
- Course 1: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and
oral prednisone on days 1-7. Allopurinol PO will be given on days 1-14.
- Courses 2, 4, and 6: Patients receive ifosfamide IV over 1 hour daily on days 1-5;
vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin
calcium IV over 15 minutes every 6 hours on day 2; cytarabine IV over 2 hours on days 4
and 5 and etoposide IV over 1 hour daily on days 4 and 5; oral dexamethasone daily on
days 1-5; and methotrexate and cytarabine intrathecally (IT) on day 1. During course 2,
patients receive rituximab IV over 1-4 hours on days 8, 10, and 12. During courses 4
and 6, patients receive rituximab IV over 1 hour on day 8. Patients also receive
filgrastim (G-CSF) subcutaneously (SC) beginning on day 7 and continuing until blood
counts recover.
- Courses 3, 5, and 7: Patients receive cyclophosphamide IV over 5-15 minutes daily on
days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1;
leucovorin calcium IV every 6 hours on day 2; doxorubicin IV daily on days 4 and 5;
oral dexamethasone daily on days 1-5; methotrexate and cytarabine IT on day 1; and
rituximab IV over 1 hour on day 8. Patients also receive G-CSF as in courses 2, 4, and
6. After course 3, treatment continues in the absence of disease progression or
unacceptable toxicity.
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.
- Determine the complete response rate in patients with previously untreated Burkitt's
lymphoma or Burkitt's leukemia treated with rituximab and high-intensity chemotherapy
with filgrastim (G-CSF) support.
- Determine the progression-free and overall survival of patients treated with this
regimen.
- Determine the feasibility and toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia
vs lymphoma).
- Course 1: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and
oral prednisone on days 1-7. Allopurinol PO will be given on days 1-14.
- Courses 2, 4, and 6: Patients receive ifosfamide IV over 1 hour daily on days 1-5;
vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin
calcium IV over 15 minutes every 6 hours on day 2; cytarabine IV over 2 hours on days 4
and 5 and etoposide IV over 1 hour daily on days 4 and 5; oral dexamethasone daily on
days 1-5; and methotrexate and cytarabine intrathecally (IT) on day 1. During course 2,
patients receive rituximab IV over 1-4 hours on days 8, 10, and 12. During courses 4
and 6, patients receive rituximab IV over 1 hour on day 8. Patients also receive
filgrastim (G-CSF) subcutaneously (SC) beginning on day 7 and continuing until blood
counts recover.
- Courses 3, 5, and 7: Patients receive cyclophosphamide IV over 5-15 minutes daily on
days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1;
leucovorin calcium IV every 6 hours on day 2; doxorubicin IV daily on days 4 and 5;
oral dexamethasone daily on days 1-5; methotrexate and cytarabine IT on day 1; and
rituximab IV over 1 hour on day 8. Patients also receive G-CSF as in courses 2, 4, and
6. After course 3, treatment continues in the absence of disease progression or
unacceptable toxicity.
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.
DISEASE CHARACTERISTICS:
- Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia
or Burkitt's or Burkitt-like lymphoma
- L3 morphology surface IgG expression
- Cytogenetic evidence for t(8;14), t(8;22), or t(2;8)
- Previously untreated disease except hydroxyurea for leukocytosis
- CNS involvement allowed
- Patients with Burkitt's leukemia or Burkitt's lymphoma with bone marrow involvement
must also be enrolled on CALGB-8461
- Patients with Burkitt's leukemia must also be enrolled on CALGB-9665
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- HIV negative
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent interleukin-11
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except for non-disease-related conditions (e.g.,
insulin for diabetes)
- No concurrent steroids except for adrenal failure
Radiotherapy:
- No concurrent palliative radiotherapy except whole-brain irradiation for documented
CNS disease
We found this trial at
31
sites
4701 Ogletown-Stanton Road
Newark, Delaware 19713
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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200 Hawthorne Lane
Charlotte, North Carolina 28233
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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115 Business loop 70 w
Columbia, Missouri 65203
Columbia, Missouri 65203
(573) 882-2100
Ellis Fischel Cancer Center at University of Missouri - Columbia At Ellis Fischel Cancer Center,...
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Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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200 Hawkins Drive
Iowa City, Iowa 52242
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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One Medical Center Drive
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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902 Savannah Road
Lewes, Delaware 19958
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
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425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Comprehensive Cancer Center The Comprehensive Cancer Center at Rhode Island Hospital is...
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401 College Street
Richmond, Virginia 23298
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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Mountainview Medical Our medical oncologists, hematologist, and oncology advanced practice nurse, along with other dedicated...
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1351 Kimberly Rd
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
Chicago, Illinois 60612
312.355.1625
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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300 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(800) 293-5066
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center...
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Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Stony Brook, New York 11794
(631) 638-1000
Stony Brook University Cancer Center Ask a cancer survivor. Having highly advanced care close to...
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6900 Georgia Ave NW
Washington, District of Columbia 20307
Washington, District of Columbia 20307
(202) 782-6849
Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
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