A clinical trial to study the effects of Lucanix (Test Drug) in patients suffering from advanced non small cell Lung Cancer who have previously responded to or have a stable disease following treatment with platinum based combination chemotherapy.
- Conditions
- Health Condition 1: null- Non-Small Cell Lung Cancer
- Registration Number
- CTRI/2010/091/000486
- Lead Sponsor
- ovaRx Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 700
oSubjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
Stage IIIA (T3N2 only) or
Stage IIIB or
Stage IV.
oSubjects must have stable disease (SD) or better following 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.
oNot 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.
oSubjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months. Signed informed consent.
oNot less than 18 years and not more than 75 years old.
oEstimated life expectancy of at least 12 weeks.
oPerformance status (ECOG) ≤ 2.
oAbsolute neutrophil count ≥ 1,500/mm3.
oHemoglobin ≥ 9 g/dL.
oPlatelet count ≥ 100,000/mm3.
oAlbumin levels ≥ 2.5 g/dL.
oBilirubin ≤ 1.5 times the upper limit of normal (ULN).
oAspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 Ã? ULN.
oCreatinine ≤ 1.5 Ã? ULN.
oAlkaline phosphatase ≤ 5 Ã? ULN
oConcurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
oPrior splenectomy.
oAny surgery involving general anesthesia < 4 weeks prior to study registration.
oChemotherapy more than 4 months or less than 4 weeks prior to study registration.
oSteroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, other investigational products or immunotherapy less than 4 weeks prior to study registration.
oSubjects 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.
oPainful bone metastases, or bone metastases that require immediate therapy.
oSignificant 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.
oKnown allergies to eggs or soy.
oSignificant weight loss (≥ 10% body weight in preceding 6 weeks).
oKnown HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
oSerious 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.
oNCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
oPrior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
oHistory of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
oPregnant 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.
oKnown active Epstein-Barr infection within ≤ 60 days of study registration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix?) vs placebo.Timepoint: The primary analysis time point for all outcome variables will be the time of the primary analysis <br/ ><br>for overall survival.
- Secondary Outcome Measures
Name Time Method Evaluate the progression free survival (PFS) of subjects treated with Lucanix compared to treatment within the Best Support Care (BSC)control group.Timepoint: PFS and TTP will be analyzed using the same methods as described for the primary endpoint.PFS will be calculated from the date of randomization to the date of documented tumor <br/ ><br>progression (i.e. the date of the initial scan that detects tumor progression) or death from any cause and will be censored at the date of the last contact for subjects who are lost-to-follow-up or <br/ ><br>who are alive at the time of analysis.