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.

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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

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT00217425

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 92 Locations for this study

See Locations Near You

California Cancer Care, Incorporated - Greenbrae
Greenbrae California, 94904, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto California, 94304, United States
Front Range Cancer Specialists
Fort Collins Colorado, 80528, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60504, United States
St. Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Hematology and Oncology Associates
Chicago Illinois, 60611, United States
Eureka Community Hospital
Eureka Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex
Hopedale Illinois, 61747, United States
Midwest Center for Hematology/Oncology
Joliet Illinois, 60432, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville Illinois, 60048, United States
McDonough District Hospital
Macomb Illinois, 61455, United States
La Grange Oncology Associates - Geneva
Naperville Illinois, 60563, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles Illinois, 60714, United States
BroMenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center
Normal Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria Illinois, 61637, United States
Illinois Valley Community Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
Swedish-American Regional Cancer Center
Rockford Illinois, 61104, United States
Hematology Oncology Associates - Skokie
Skokie Illinois, 60076, United States
St. Margaret's Hospital
Spring Valley Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Greater Baltimore Medical Center Cancer Center
Baltimore Maryland, 21204, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Green Bay Oncology, Limited - Escanaba
Escanaba Michigan, 49431, United States
Dickinson County Healthcare System
Iron Mountain Michigan, 49801, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park Minnesota, 55416, United States
United Hospital
Saint Paul Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Aultman Cancer Center at Aultman Hospital
Canton Ohio, 44710, United States
St. Rita's Medical Center
Lima Ohio, 45801, United States
Doylestown Hospital Cancer Center
Doylestown Pennsylvania, 18901, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Central Pennsylvania Hematology and Medical Oncology Associates, PC
Lemoyne Pennsylvania, 17043, United States
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
Mount Nittany Medical Center
State College Pennsylvania, 16803, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette Wisconsin, 54143, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls Wisconsin, 54154, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay Wisconsin, 54235, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT00217425

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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