Status:
COMPLETED
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
Lead Sponsor:
ECOG-ACRIN Cancer Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 abili...
Detailed Description
OBJECTIVES: Primary * To determine the safety of BLP25 liposome vaccine (tecemotide) and bevacizumab after definitive chemoradiotherapy and consolidation chemotherapy in patients with newly diagnose...
Eligibility Criteria
Inclusion
- Step 1
- 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
- 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
Key Trial Info
Start Date :
January 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00828009
Start Date
January 17 2011
End Date
May 22 2019
Last Update
July 7 2023
Active Locations (88)
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1
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304
2
Stanford Cancer Center
Stanford, California, United States, 94305-5824
3
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
4
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701