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BLP25 Liposome Vaccine and Be...

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

Last Updated: 2023-07-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-17

Study Completion Date

2019-05-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tecemotide/bevacizumab after chemoradiation

Concomitant Chemoradiotherapy: Patients (pts) receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 15-30 minutes weekly for 6 weeks. Pts also receive radiotherapy 5 days a week for 6½ weeks. Pts with CR, PR, or SD proceed to consolidation chemotherapy.

Consolidation chemotherapy: Pts 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 (PD) or unacceptable toxicity. Pts with CR, PR, or SD proceed to maintenance therapy.

Maintenance therapy: Pts receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and tecemotide. Pts then receive bevacizumab IV over 30-90 minutes on day 1 and tecemotide 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 PD or unacceptable toxicity.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

Tecemotide

Intervention Type BIOLOGICAL

carboplatin

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiotherapy

Intervention Type RADIATION

radiotherapy is given 5 days a week for 6½ weeks during concomitant chemoradiotherapy

Interventions

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bevacizumab

Intervention Type BIOLOGICAL

Tecemotide

Intervention Type BIOLOGICAL

carboplatin

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiotherapy

radiotherapy is given 5 days a week for 6½ weeks during concomitant chemoradiotherapy

Intervention Type RADIATION

Other Intervention Names

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NSC 704865 RhuMAb VEGF Recombinant Humanized Monoclonal Bevacizumab Antibody L-BLP25 CBDCA paraplatin JM-8 NSC 241240 Cytoxan Neosar CTX CPM taxol NSC #673089

Eligibility Criteria

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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

* 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

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

* Progressive disease or unevaluable disease per RECIST criteria upon post- consolidation chemotherapy evaluation
* Autoimmune disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jyoti D. Patel

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

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Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, United States

Site Status

Stanford Cancer Center

Stanford, California, United States

Site Status

Medical Center of Central Georgia

Macon, Georgia, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Hematology and Oncology Associates

Chicago, Illinois, United States

Site Status

Saint Joseph Hospital

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Kellogg Cancer Care Center

Highland Park, Illinois, United States

Site Status

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

Site Status

Provena St. Mary's Regional Cancer Center - Kankakee

Kankakee, Illinois, United States

Site Status

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Moline, Illinois, United States

Site Status

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Swedish-American Regional Cancer Center

Rockford, Illinois, United States

Site Status

Hematology Oncology Associates - Skokie

Skokie, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Site Status

Saint Joseph Regional Medical Center

Mishawaka, Indiana, United States

Site Status

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status