Status:
COMPLETED
Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy
Lead Sponsor:
NovaRx Corporation
Conditions:
Lung Neoplasm
Carcinoma Non-small Cell Lung Cancer Stage IIIA
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as ...
Detailed Description
Primary Efficacy Endpoints: * Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo. Secondary Efficacy Endpo...
Eligibility Criteria
Inclusion
- Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
- Stage IIIA (T3N2 only) or
- Stage IIIB or
- Stage IV.
- Subjects must have stable disease (SD) or an objective response (PR or CR) to a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
- Not less than four weeks nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
- Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
- Signed informed consent.
- Not less than 18 years and not more than 75 years old.
- Estimated life expectancy of at least 12 weeks.
- Performance status (ECOG) ≤ 2.
- Absolute neutrophil count ≥ 1,500/mm3.
- Hemoglobin ≥ 9 g/dL.
- Platelet count ≥ 100,000/mm3.
- Albumin levels ≥ 2.5 g/dL.
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
- Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
- Creatinine ≤ 1.5 × ULN.
- Alkaline phosphatase ≤ 5 × ULN.
Exclusion
- Concurrent systemic steroids \> 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
- Prior splenectomy.
- Any surgery involving general anesthesia \< 4 weeks prior to study registration.
- Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
- Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration.
- Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
- Painful bone metastases, or bone metastases that require immediate therapy.
- Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
- Known allergies to eggs or soy.
- Significant weight loss (≥ 10% body weight in preceding 6 weeks).
- Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
- Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
- NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
- Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
- History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
- Pregnant or nursing women, or refusal to practice contraception if of reproductive potential.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Known active Epstein-Barr infection within ≤ 60 days of study registration.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT00676507
Start Date
July 1 2008
End Date
January 1 2013
Last Update
May 8 2015
Active Locations (82)
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1
Southern Cancer Center
Mobile, Alabama, United States, 36608
2
Alaska Regional Hospital
Anchorage, Alaska, United States, 99508
3
Mayo Clinic Cancer Center
Scottsdale, Arizona, United States, 85259
4
Clopton Clinic Hematology/Oncology
Jonesboro, Arkansas, United States, 72401