Non Hodgkin Lymphoma Clinical Trial
Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms
Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with several chemotherapy drugs (combination chemotherapy) works in treating patients with peripheral T-cell lymphoma or natural killer cell neoplasms.
Full Description
OBJECTIVES:
Primary
Determine the 12-month progression-free survival of patients with peripheral T-cell or natural killer cell neoplasms treated with bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP).
Secondary
Determine the overall response rate (complete remission [CR, unconfirmed CR, or functional CR] and partial remission) in these patients after courses 3, 6, and 8 of this treatment regimen.
Determine the overall survival of patients treated with this regimen.
Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive 6-8 cycles of 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.
After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 22 months.
ACTUAL ACCRUAL: 46
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 92 Locations for this study
Greenbrae California, 94904, United States
Palo Alto California, 94304, United States
Fort Collins Colorado, 80528, United States
Aurora Illinois, 60504, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Joliet Illinois, 60432, United States
Libertyville Illinois, 60048, United States
Macomb Illinois, 61455, United States
Naperville Illinois, 60563, United States
Niles Illinois, 60714, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Rockford Illinois, 61104, United States
Skokie Illinois, 60076, United States
Spring Valley Illinois, 61362, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46202, United States
Michigan City Indiana, 46360, United States
Ames Iowa, 50010, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21231, United States
Escanaba Michigan, 49431, United States
Iron Mountain Michigan, 49801, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
Bronx New York, 10466, United States
Akron Ohio, 44309, United States
Canton Ohio, 44710, United States
Lima Ohio, 45801, United States
Doylestown Pennsylvania, 18901, United States
Hershey Pennsylvania, 17033, United States
Lemoyne Pennsylvania, 17043, United States
Lewistown Pennsylvania, 17044, United States
Philadelphia Pennsylvania, 19111, United States
State College Pennsylvania, 16803, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Nashville Tennessee, 37232, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
Madison Wisconsin, 53792, United States
Marinette Wisconsin, 54143, United States
Oconto Falls Wisconsin, 54154, United States
Sturgeon Bay Wisconsin, 54235, United States
How clear is this clinincal trial information?