A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to whether the patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT (yes vs no).
Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over 30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone orally on days 1-5. Treatment repeats every 21 days for 3* courses. NOTE: *Patients found to have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of R-CHOP.
FDG/PET - Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion of course 3. Patients with complete response (PET scan negative) receive one additional course of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.
Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or 9.
Patients may undergo blood sample collection at baseline for correlative studies. Bone marrow tissue samples may be also collected for correlative studies.
After completion of study therapy, patients are followed up every 6 months for 2 years and then yearly for 5 years.
DISEASE CHARACTERISTICS:
Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)
Patients must have non-bulky stage I or II disease by Ann Arbor classification
Patients must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to registration
Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma
Patients may have either measurable or evaluable limited-stage DLBCL
Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration
PATIENT CHARACTERISTICS:
Zubrod performance status 0-2
Absolute neutrophil count (ANC) ≥ 1,000/mm³
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome)
Patients must not be pregnant or nursing
Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period
Patients must not be known to be HIV-positive
No other prior malignancy is allowed except for the following:
PRIOR CONCURRENT THERAPY:
Tucson, Arizona 85724-5024, United States
Grand Junction, Colorado 81502, United States
Hartford, Connecticut 06105, United States
Boise, Idaho 83706, United States
Boise, Idaho 83712, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
Wichita, Kansas 67214, United States
Lexington, Kentucky 40536-0093, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
St Louis, Missouri 63110, United States
Billings, Montana 59102, United States
Missoula, Montana 59807, United States
Rochester, New York 14642, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
San Antonio, Texas 78229-3900, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195, United States
Morgantown, West Virginia 26506, United States