Status:
WITHDRAWN
Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Resectable Non-Small Cell Lung Cancer
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Despite recent advances in the treatment of patients with resected NSCLC, disease recurrence and mortality related to lung cancer are common among patients with early stage non-small cell lung cancer ...
Detailed Description
In the currently proposed study, patients will receive the first dose of the vaccine approximately 2 weeks prior to surgery. The second dose will be administered about 3-4 weeks following surgery. A b...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed non-small cell lung cancer
- All patients must have one of the following stages: Stage IA(T1NO), and IB T2NO), II \& IIIA (N2 negative)
- No prior chemotherapy or radiation therapy for non-small cell lung cancer
- Age \>18 years
- ECOG performance status \<2
- Patients must have acceptable organ and marrow
- Patient must be deemed surgically and medically resectable
- Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients may not be receiving any other investigational agents.
- Patients should not have received chemotherapy or radiotherapy within 3 months prior to entry to study.
- Patients with tumors involving the superior sulcus are not eligible.
- Patients must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test.
- Known HIV-positive patients are excluded from the study.
- Patients with a history of known autoimmune disease are excluded from this study.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01398124
Start Date
December 1 2012
End Date
December 1 2015
Last Update
August 22 2017
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