BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/28/2019 |
Start Date: | December 22, 2010 |
End Date: | May 22, 2019 |
A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB Non-Squamous Non-Small Cell Lung Cancer After Definitive Chemoradiation
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine
therapy together with bevacizumab after chemotherapy and radiation therapy may kill more
tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccine
together with bevacizumab after chemotherapy and radiation therapy in treating patients with
newly diagnosed stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by
surgery.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine
therapy together with bevacizumab after chemotherapy and radiation therapy may kill more
tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccine
together with bevacizumab after chemotherapy and radiation therapy in treating patients with
newly diagnosed stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by
surgery.
OBJECTIVES:
Primary
- To determine the safety of BLP25 liposome vaccine (tecemotide) and bevacizumab after
definitive chemoradiotherapy and consolidation chemotherapy in patients with newly
diagnosed, unresectable stage IIIA or IIIB nonsquamous cell non-small cell lung cancer.
Secondary
- To evaluate the overall survival and progression-free in patients treated with this
regimen.
- To evaluate the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Step 1:
- Chemoradiotherapy: Patients receive paclitaxel intravenously (IV) over 1 hour and
carboplatin IV over 15-30 minutes once a week for 6 weeks. Patients also undergo
concurrent definitive radiotherapy 5 days a week for 6½ weeks. Patients with complete
response (CR), partial response (PR), or stable disease (SD) proceed to consolidation
chemotherapy.
- Consolidation chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin
IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the
absence of disease progression or unacceptable toxicity. Patients with CR, PR, or SD
proceed to maintenance therapy.
Step 2:
- Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30
minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients
then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine
subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other
course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
Primary
- To determine the safety of BLP25 liposome vaccine (tecemotide) and bevacizumab after
definitive chemoradiotherapy and consolidation chemotherapy in patients with newly
diagnosed, unresectable stage IIIA or IIIB nonsquamous cell non-small cell lung cancer.
Secondary
- To evaluate the overall survival and progression-free in patients treated with this
regimen.
- To evaluate the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Step 1:
- Chemoradiotherapy: Patients receive paclitaxel intravenously (IV) over 1 hour and
carboplatin IV over 15-30 minutes once a week for 6 weeks. Patients also undergo
concurrent definitive radiotherapy 5 days a week for 6½ weeks. Patients with complete
response (CR), partial response (PR), or stable disease (SD) proceed to consolidation
chemotherapy.
- Consolidation chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin
IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the
absence of disease progression or unacceptable toxicity. Patients with CR, PR, or SD
proceed to maintenance therapy.
Step 2:
- Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30
minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients
then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine
subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other
course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
Step 1 Inclusion Criteria:
- Histologically confirmed newly diagnosed nonsquamous non-small cell lung cancer
(NSCLC), including the following subtypes:
- Adenocarcinoma
- Large cell undifferentiated
- Bronchoalveolar cell
- non-small cell carcinoma, not otherwise specified
- Unresectable stage IIIA or stage IIIB disease
- Patients with stage IIIA disease with mediastinal lymph node enlargement between
1 cm and 2.0 cm on computerized tomography (CT) scan must have these nodes
biopsied (pathologic confirmation) to rule out resectability
- Metastases to contralateral mediastinal or supraclavicular nodes allowed
- Measurable or non-measurable disease, as defined by Response Evaluation Criteria in
Solid Tumours (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- White blood cell (WBC) ≥ 4,000/mm³ OR Absolute neutrophil count (ANC) ≥ 2,000/mm³
- Platelet count ≥ 140,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 mg/dL
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)+ ≤ 2.5 times upper
limit of normal
- Serum creatinine ≤ 1.5 mg/mL OR creatinine clearance ≥ 45 mL/min
- Urine protein:creatinine ratio < 1.0 by urine dipstick OR < 1 g of protein by 24-hour
urine collection
- INR ≤ 1.5 OR ≤ 3.0 if patient is on therapeutic anticoagulation
- PTT normal
- Fertile patients must use effective contraception before, during, and for ≥ 6 months
after completion of bevacizumab
Step 1 Exclusion Criteria:
- Significant pleural effusion
- CNS metastases by head CT scan or MRI within the past 4 weeks
- Pregnant or breast-feeding
- Prior chemotherapy or monoclonal antibodies for other cancers within 5 years prior to
registration
- Prior chemotherapy for lung cancer
- Prior chest radiotherapy
- Ongoing (lasting > 14 days) or active infection or ongoing (lasting > 14 days) fever
within the past 6 months
- Gross hemoptysis ≥ grade 2 (defined as ≥ ½ teaspoon of bright red blood per episode)
within the past 3 months
- Bleeding ≥ grade 2 or any bleeding requiring intervention
- Clinically significant cardiovascular disease
- Myocardial infarction within the past 6 months
- New York Heart Association class III-IV congestive heart failure
- Unstable angina pectoris
- Serious cardiac arrhythmia requiring medication within the past 4 weeks
- History of hypertensive crisis or hypertensive encephalopathy
- Stroke or transient ischemic attack within the past 6 months
- Peripheral vascular disease ≥ grade 2 within the past 6 months
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the
past 6 months
- Psychiatric illness or social situation that would limit compliance with study
requirements
- History of uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg) while on
stable regimen of antihypertensive therapy
- Significant traumatic injury or serious non-healing wound, ulcer, or bone fracture
within the past 4 weeks
- Concurrent major surgical procedure
- Having anticipated major surgical procedure(s) during the course of the study
- Concurrent daily aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents
(NSAIDs) known to inhibit platelet function
- Recognized immunodeficiency disease, including cellular immunodeficiencies,
hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital
immunodeficiencies
- Pre-existing medical condition requiring chronic steroids or immunosuppressive therapy
- Autoimmune disease
- Known hepatitis B or C
- Immunotherapy (e.g., interferon, interleukin, sargramostim [GM-CSF], or filgrastim
[G-CSF]) within 28 days prior to registration
- Prior splenectomy
- Hypersensitivity to any component of bevacizumab
- Prior core biopsy or any other minor surgical procedure, excluding the placement of a
vascular access device, within 7 days prior to registration
Step 2 Inclusion Criteria:
- Serum creatinine ≤ 1.5 mg/ml or calculated creatinine clearance ≥ 45 ml/min
- Urine dipstick must be ≤ 0-1+. If urine dipstick results > 1+, 24 hour urine for
protein must be obtained. Patients must have < 1g protein/24 hours to participate in
the study
- Patient must be registered to step 2 within 28 days of completion of consolidation
chemotherapy
- Patient must have met all eligibility requirements for Step 1
- Platelets ≥ 100,000/mm3
Step 2 Exclusion Criteria:
- Progressive disease or unevaluable disease per RECIST criteria upon post-
consolidation chemotherapy evaluation
- Autoimmune disease
We found this trial at
88
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
(610) 402-8000
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 695-1156
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2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
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100 North Academy Ave
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
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500 University Drive
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-8521
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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1900 South Avenue
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
(608) 782-7300
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
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Graham Hospital At Graham Hospital, we have a proud and rich history of serving the...
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Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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3110 MacCorkle Ave. S.E.
Charleston, West Virginia 25304
Charleston, West Virginia 25304
304-347-1206
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West Virginia University Health Sciences Center - Charleston The West Virginia University Robert C. Byrd...
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Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
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Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
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Parkland Memorial Hospital As our community's public health system, Parkland is the foundation for a...
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2300 N. Edward Street
Decatur, Illinois 62526
Decatur, Illinois 62526
217-876-8121
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Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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1221 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-4141
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
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411 Laurel St New Visions
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3970
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411 Laurel Street
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3121
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
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Galesburg Clinic, PC OSF Galesburg Clinic, located on the OSF St. Mary Medical Center campus,...
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One Ingalls Drive
Harvey, Illinois 60426
Harvey, Illinois 60426
708.333.2300
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Mason District Hospital Mason District Hospital is dedicated to providing superior healthcare close to home...
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Geisinger Hazleton Cancer Center At the Geisinger Cancer Institute, we strive to better understand cancer...
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Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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100 Provena Way
Kankakee, Illinois 60914
Kankakee, Illinois 60914
815.937.8780
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1007 LINCOLNWAY
La Porte, Indiana 46350
La Porte, Indiana 46350
219.326.1234
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Lewistown Hospital Geisinger-Lewistown Hospital, non-profit organization, is a 123-bed acute care community hospital serving the...
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1800 Hollister Drive, Suite 112
Libertyville, Illinois 60048
Libertyville, Illinois 60048
847-367-6781
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St. Rita's Medical Center Welcome to St. Rita's Medical Center. As the region's leader in...
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McDonough District Hospital McDonough District Hospital is centered in Macomb, Illinois, home to Division 1...
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Saint Joseph Regional Medical Center Saint Joseph Regional Medical Center is a not-for-profit, multi-hospital health...
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500 John Deere Road
Moline, Illinois 61265
Moline, Illinois 61265
(309) 779-5000
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195 Little Albany St
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
(732) 235-2465
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8915 W Golf Rd
Niles, Illinois 60714
Niles, Illinois 60714
(847) 827-9060
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BroMenn Regional Medical Center Advocate BroMenn Medical Center is a general medical and surgical hospital...
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791 Summit Avenue
Oconomowoc, Wisconsin 53066
Oconomowoc, Wisconsin 53066
262-569-9400
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Immanuel Medical Center Welcome to Alegent Creighton Immanuel Medical Center. Our campus, located in North...
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7500 Mercy Rd
Omaha, Nebraska 68124
Omaha, Nebraska 68124
(402) 398-6060
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Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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Community Hospital of Ottawa Ottawa Regional Hospital, an acute care medical facility, is located on...
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Cancer Treatment Center at Pekin Hospital Since 1913, Pekin Hospital has been dedicated to improving...
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OSF St. Francis Medical Center OSF Saint Francis Medical Center, licensed for 616 beds and...
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Proctor Hospital Proctor Hospital provides unmatched healthcare experiences…every day. In fact, it’s our mission. Licensed...
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Methodist Medical Center of Illinois UnityPoint Health is one of the nation's most integrated health...
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Illinois Valley Community Hospital People
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Perry Memorial Hospital Services at Perry include the Perry Memorial Orthopedic and Sports Medicine Clinic;...
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3535 N Bell School Rd
Rockford, Illinois 61114
Rockford, Illinois 61114
(779) 696-9400
![Swedish-American Regional Cancer Center](/wp-content/uploads/logos/swedish-american-regional-cancer-center.jpg)
Swedish-American Regional Cancer Center The SwedishAmerican Regional Cancer Center offers state-of-the-art treatment and support services...
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Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
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Mercy Medical Center - Sioux City Living the traditions, visions and values of the Sisters...
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St. Luke's Regional Medical Center St. Luke's is a patient and family-centered hospital that delivering...
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Memorial Hospital of South Bend Memorial Hospital of South Bend is a community-owned, not-for-profit corporation...
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701 N 1st St
Springfield, Illinois 62781
Springfield, Illinois 62781
(217) 788-4400
![Regional Cancer Center at Memorial Medical Center](/wp-content/uploads/logos/regional-cancer-center-at-memorial-medical-center.png)
Regional Cancer Center at Memorial Medical Center At Memorial's Regional Cancer Center, we understand the...
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200 Scenery Drive
State College, Pennsylvania 16801
State College, Pennsylvania 16801
814-231-4560
![Geisinger Medical Group - Scenery Park](/wp-content/uploads/logos/geisinger-medical-group---scenery-park.jpg)
Geisinger Medical Group - Scenery Park Geisinger-Scenery Park provides an impressive array of healthcare right...
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Mount Nittany Medical Center Mount Nittany Medical Center is a 260-bed acute care facility offering...
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Stony Brook, New York 11794
(631) 638-1000
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Stony Brook University Cancer Center Ask a cancer survivor. Having highly advanced care close to...
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725 American Ave
Waukesha, Wisconsin 53188
Waukesha, Wisconsin 53188
(262) 928-1000
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Waukesha Memorial Hospital Regional Cancer Center ProHealth Care is proud to offer sophisticated technology and...
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1000 E. Mountain Blvd.
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
570-808-6150
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Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center The Frank...
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