Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms
Lymphoma

About this trial
This is an interventional treatment trial for Lymphoma focused on measuring anaplastic large cell lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, peripheral T-cell lymphoma
Eligibility Criteria
INCLUSION CRITERIA: Diagnosis of peripheral T-cell or natural killer cell neoplasm Any stage disease allowed HTLV-positive tumors allowed At least one objective measurable disease parameter. Abnormal positron emission tomography scans are not considered evidence of measurable disease unless results are confirmed by CT scan or other appropriate imaging techniques Age 18 and over ECOG Performance status 0-2 Absolute neutrophil count ≥ 1,000/mm^3(500/mm^3 if due to bone marrow involvement with lymphoma) Platelet count ≥ 100,000/mm^3(50,000/mm^3 if due to bone marrow involvement with lymphoma) Bilirubin ≤ 2.0 mg/dL (≤ 3 times upper limit of normal [ULN] if due to hepatic involvement with lymphoma) AST ≤ 2 times ULN (5 times ULN if due to hepatic involvement with lymphoma) PT, INR, and PTT ≤ 1.5 times normal Creatinine ≤ 2.0 mg/dL Urinary protein:creatinine ratio ≤ 1 History of deep venous thrombosis allowed provided patient is on a stable dose of anticoagulants for at least 2 weeks prior to study entry LVEF ≥ 50% History of pulmonary embolism allowed provided patient is on a stable dose of anticoagulants for at least 2 weeks prior to study entry One prior cycle of CHOP for PTCL allowed More than 4 weeks since prior major invasive surgery or open biopsy At least 7 days since prior minor surgery. Peripheral lymph node core biopsy, bone marrow biopsy, fine needle aspiration, skin biopsy, or central line placement are not considered minor surgical procedures More than 7 days since prior and no concurrent anti-platelet drugs (e.g., ticlopidine, clopidogrel, or cilostazol) except aspirin or other nonsteroidal anti-inflammatory drugs Concurrent anticoagulants allowed provided patient is on a stable dose INR must be stable for at least 2 weeks prior to study entry PT/INR and/or PTT must be closely monitored and levels kept within acceptable range for underlying thrombotic disease Concurrent heparin flush for maintenance of central line patency allowed EXCLUSION CRITERIA: Anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma. ALK-negative T-cell large cell lymphoma allowed Cutaneous T-cell lymphoma History of or current radiographic evidence of CNS metastasis, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement Evidence of bleeding diathesis or coagulopathy Cerebrovascular accident within the past 6 months Myocardial infarction within the past 6 months Unstable angina within the past 6 months New York Heart Association class II-IV congestive heart failure Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg) Other clinically significant cardiovascular or peripheral vascular disease Abdominal fistula within the past 6 months Gastrointestinal perforation within the past 6 months Intra-abdominal abscess within the past 6 months Concurrent major surgery Pregnant or nursing. Female patients must have negative pregnancy test. Fertile patients must use effective contraception History of active seizures Significant traumatic injury within the past 4 weeks Non-healing ulcer (unless involved with lymphoma) Bone fracture Active infection requiring parenteral antibiotics HIV positivity Other active malignancy within the past 6 months except carcinoma in situ of the cervix or basal cell carcinoma of the skin
Sites / Locations
- California Cancer Care, Incorporated - Greenbrae
- Veterans Affairs Medical Center - Palo Alto
- Front Range Cancer Specialists
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Midwest Center for Hematology/Oncology
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- McDonough District Hospital
- La Grange Oncology Associates - Geneva
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- Swedish-American Regional Cancer Center
- Hematology Oncology Associates - Skokie
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Indiana University Melvin and Bren Simon Cancer Center
- Saint Anthony Memorial Health Centers
- McFarland Clinic, PC
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Greater Baltimore Medical Center Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Green Bay Oncology, Limited - Escanaba
- Dickinson County Healthcare System
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Summa Center for Cancer Care at Akron City Hospital
- Aultman Cancer Center at Aultman Hospital
- St. Rita's Medical Center
- Doylestown Hospital Cancer Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Central Pennsylvania Hematology and Medical Oncology Associates, PC
- Lewistown Hospital
- Fox Chase Cancer Center - Philadelphia
- Mount Nittany Medical Center
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Vanderbilt-Ingram Cancer Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
Arms of the Study
Arm 1
Experimental
Treatment (A-CHOP followed by MA)
Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.