A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)

Patients must have biopsy-proven Diffuse Large B-cell Lymphoma. Patients with primary
mediastinal lymphoma or testicular lymphoma are not eligible. Patients must have non-bulky Stage I or II disease by Ann Arbor classification. This staging excludes FDG-PET evaluation. Patients who have Stage I or
II non-bulky disease based on diagnostic CT scan, but are upstaged to Stage III or IV
based on FDG-PET evaluation are also eligible.
Patients must have a diagnostic quality contrast-enhanced CT scan of the chest,
abdomen and pelvis AND baseline FDG-PET scan prior to registration. Low resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol. Patients must not have clinical evidence of central nervous system involvement by lymphoma, since proposed treatment would not be able to address it adequately. All patients must have bidimensionally measurable disease. Patients must have a unilateral or bilateral bone marrow biopsy performed. Pathology Review: Adequate sections or a paraffin block from the original diagnostic specimen must be submitted for review by the lymphoma pathology group. The lymphoma must express the CD20 antigen by either flow cytometry using anti-CD20 antibodies or by immunoperoxidase staining of paraffin sections. Patients must have passed their 18th birthday. Patients must not have received prior chemotherapy, radiation, or antibody therapy for lymphoma. Patients must have a Zubrod performance status of 0 - 2. The following tests must be performed prior to registration either for diagnosis/staging or to obtain baseline values:
a. WBC
b. Hemoglobin
c. LDH
d. Serum creatinine
e. AST/ALT
Patients must have platelet count �� 100,000 cells/mcL and ANC �� 1,000 cells/mcL within 42 days prior to registration. Patients must have total bilirubin �� 2 x Institutional Upper Limit of Normal (IULN) (unless due to Gilbert��s Syndrome) within 42 days prior to registration. Patients must not be known to be HIV-positive due to poor specificity of PET/CT scans in this population. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study period. All patients must be informed of the investigational nature of this study.