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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

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


OBJECTIVES:

Primary

- To determine the safety of BLP25 liposome vaccine 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.

- Chemoradiotherapy: Patients receive paclitaxel 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.

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed nonsquamous cell non-small cell lung cancer
(NSCLC), including the following subtypes:

- Adenocarcinoma

- Large cell undifferentiated

- Bronchoalveolar cell

- NSCLC, 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 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 RECIST criteria

- No significant pleural effusion as defined by either of the following:

- Pleural effusion is seen on CT scan only (not seen on chest x-ray)

- Pleural effusion does not reaccumulate within 1 week after thoracentesis AND is
cytologically negative

- No CNS metastases by head CT scan or MRI within the past 4 weeks

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- WBC ≥ 4,000/mm³ OR ANC ≥ 2,000/mm³

- Platelet count ≥ 140,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- Total bilirubin ≤ 1.5 mg/dL

- AST/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

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception before, during, and for ≥ 6 months
after completion of bevacizumab

- No other active malignancies

- No known hepatitis B or C

- No ongoing (lasting > 14 days) or active infection or ongoing (lasting > 14 days)
fever within the past 6 months

- No gross hemoptysis ≥ grade 2 (defined as ≥ ½ teaspoon of bright red blood per
episode) within the past 3 months

- No pulmonary hemoptysis

- Confirmed extrapulmonary hemoptysis allowed

- No bleeding ≥ grade 2 or any bleeding requiring intervention

- No history of bleeding diathesis or coagulopathy

- No cardiac dysfunction, including any of the following:

- 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

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- No psychiatric illness or social situation that would limit compliance with study
requirements

- No history of uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg) while
on stable regimen of antihypertensive therapy

- No significant traumatic injury or serious non-healing wound, ulcer, or bone fracture
within the past 4 weeks

- No recognized immunodeficiency disease, including cellular immunodeficiencies,
hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital
immunodeficiencies

- No pre-existing medical condition requiring chronic steroids or immunosuppressive
therapy

- No autoimmune disease

- No known hypersensitivity to any component of bevacizumab

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 4 weeks since prior open biopsy or major surgical procedure

- More than 28 days since prior immunotherapy (e.g., interferon, interleukin,
sargramostim [GM-CSF], or filgrastim [G-CSF])

- Patients must not have had prior chemotherapy or monoclonal antibodies for other
cancers within 5 years prior to registration

- More than 7 says since prior core biopsy or any other minor surgical procedure,
excluding the placement of a vascular access device

- No prior chemotherapy for lung cancer

- No prior chest radiotherapy

- No prior splenectomy

- Concurrent stable regimen of therapeutic anticoagulation or prophylactic
anticoagulation for venous access devices allowed provided coagulation studies met
entry criteria

- No concurrent daily aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents
(NSAIDs) known to inhibit platelet function

- No concurrent dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel bisulfate
(Plavix), and/or cilostazol (Pletal)

- No concurrent major surgical procedure

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Safety Issue:

Yes

Principal Investigator

Jyoti D. Patel

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

Unspecified

Study ID:

CDR0000632611

NCT ID:

NCT00828009

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
St. Rita's Medical CenterLima, Ohio  45801
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Medical Center of Central GeorgiaMacon, Georgia  31201
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Parkland Memorial HospitalDallas, Texas  75235
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Hematology and Oncology AssociatesChicago, Illinois  60611
Eureka Community HospitalEureka, Illinois  61530
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Mason District HospitalHavana, Illinois  62644
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Cancer Center at Ball Memorial HospitalMuncie, Indiana  47303
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Stanford Cancer CenterStanford, California  94305-5824
Saint Joseph HospitalChicago, Illinois  60657
Kellogg Cancer Care CenterHighland Park, Illinois  60035
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
McFarland Clinic, PCAmes, Iowa  50010
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Regional Cancer Center at Oconomowoc Memorial HospitalOconomowoc, Wisconsin  53066
PinnacleHealth Regional Cancer Center at Polyclinic HospitalHarrisburg, Pennsylvania  17105
Galesburg Clinic, PCGalesburg, Illinois  61401
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
Provena St. Mary's Regional Cancer Center - KankakeeKankakee, Illinois  60901
Tufts Medical Center Cancer CenterBoston, Massachusetts  02111
Lakeside HospitalOmaha, Nebraska  68130