Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma
Eligibility Criteria
Documentation of Disease: 1.1 Histologically documented Hodgkin lymphoma subclassified according to the WHO modification of the Rye Classification and staged according to the modified Ann Arbor Staging Classification system. Patients must have clinical stage IA, IB, IIA or IIB. Patients with "E" extensions will be eligible if all other criteria have been met. Nodular lymphocyte predominant Hodgkin lymphoma is excluded. Core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. Fine needle aspirate (FNA) cytologies and bone marrow biopsies as the sole means of diagnosis are not acceptable. Note: Failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible. 1.2 Patients may not have a mediastinal mass > 0.33 maximum intrathoracic diameter on standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy > 10 cm in its largest diameter. 1.3 Bone marrow biopsy is required for pretreatment evaluation. Bilateral biopsies are preferred but not required. No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma. Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and > 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans). Lesions that are considered intrinsically non-measurable include the following: bone lesions leptomeningeal disease ascites pleural/pericardial effusion inflammatory breast disease lymphangitis cutis/pulmonis abdominal masses that are not confirmed and followed by imaging techniques cystic lesions lesions that are situated in a previously irradiated area Age ≥ 16 years Performance status 0-2 LVEF by ECHO or MUGA within institutional normal limits DLCO ≥ 60% with no symptomatic pulmonary disease No known HIV infection. Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this chemotherapy regimen. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk. Non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control. Initial Required Laboratory Data: ANC ≥ 1000/μL Platelet count ≥ 100,000/μL Serum Creatinine ≤ 2 mg/dL Bilirubin ≤ 2 mg/dL AST ≤ 2 x upper limit of normal
Sites / Locations
- UCSF Comprehensive Cancer Center
- Beebe Medical Center
- CCOP - Christiana Care Health Services
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Walter Reed Army Medical Center
- University of Chicago Cancer Research Center
- Elkhart General Hospital
- Howard Community Hospital at Howard Regional Health System
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- Iowa Blood and Cancer Care
- St. Luke's Hospital
- Mercy Regional Cancer Center at Mercy Medical Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- Union Hospital Cancer Center at Union Hospital
- Massachusetts General Hospital Cancer Center
- Dana-Farber/Brigham and Women's Cancer Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- University of Minnesota Medical Center - Fairview
- Missouri Cancer Associates
- Siteman Cancer Center at Barnes-Jewish Hospital
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
- Great Plains Regional Medical Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- Roswell Park Cancer Institute
- Charles R. Wood Cancer Center at Glens Falls Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- CCOP - Hematology-Oncology Associates of Central New York
- SUNY Upstate Medical University Hospital
- Community General Hospital
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Lenoir Memorial Cancer Center
- Wilson Medical Center
- Wake Forest University Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Bon Secours St. Francis Health System
- CCOP - Greenville
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
Arms of the Study
Arm 1
Experimental
doxorubicin + vinblastine + gemcitabine
Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is performed 3 months later if biopsy is negative or biopsy is unable to be performed. Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.