Trial Search Results

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

The purpose of this study is to find out what effects, good and/or bad, the addition of L-BLP25 vaccine and bevacizumab to the commonly used treatment of paclitaxel, carboplatin, and thoracic radiation therapy (radiation to the chest) has on lung cancer. This research is being done because we want to see if the investigational drug L-BLP25 with bevacizumab will improve on the results of the standard treatment with paclitaxel and carboplatin. L-BLP25 may help to slow or stop the cancer cells from growing by helping the body to boost the immune system that is used to fight disease. Bevacizumab works by slowing or stopping the growth of blood vessels into tumors. Tumors need blood vessels in order to grow.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Biological: bevacizumab
  • Biological: emepepimut-S
  • Drug: carboplatin
  • Drug: cyclophosphamide
  • Drug: paclitaxel
  • Radiation: radiation therapy

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting