Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Resectable Non-Small Cell Lung Cancer
This study has been withdrawn prior to enrollment.
(We will not be pursuing this study.)
Information provided by (Responsible Party):
Chandra P. Belani, Milton S. Hershey Medical Center
First received: July 19, 2011
Last updated: January 8, 2013
Last verified: January 2013
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 (NSCLC). Therefore novel approaches are necessary to improve the outcome for early stage NSCLC. The preclinical studies conducted with vaccine based approaches provide the rationale to evaluate this as an adjunct to surgery for patients with early stage NSCLC. Administration of the vaccine before surgery will also allow for the evaluation of the tumor specimen for immunological responses to the vaccine.
Non-small Cell Lung Cancer
Biological: Cyclin B1 Peptide
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pilot Study of Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Patients With Resectable Non-Small Cell Lung Cancer
Primary Outcome Measures:
- Evaluate the ability of cyclin B1 peptide pulsed autologous dendritic cell vaccine to induce an immune response. [ Time Frame: One week after second vaccine ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Experimental: Week -2; Week 3-4; 6 months
2 weeks prior to surgery; surgery; week 3-4 2nd vaccine; 6 months after 2nd vaccine
Biological: Cyclin B1 Peptide
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 booster dose of the vaccine will be given 6 months after the 2nd vaccine. The tumor tissue and serum will be studied for immunological responses following therapy with the vaccine. Patients are allowed to receive adjuvant chemotherapy if indicated. The choice of the chemotherapy regimen will be at the discretion of the treating physician, preferably 3-4 cycles of platinum combination regimen. The vaccine should be administered at least 2 weeks before chemotherapy is initiated.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398124
Milton S. Hershey Medical Center
||Chandra P. Belani, MD
||Milton S. Hershey Medical Center
No publications provided
||Chandra P. Belani, Professor of Medicine, Milton S. Hershey Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 19, 2011
||January 8, 2013
||United States: Food and Drug Administration
Keywords provided by Milton S. Hershey Medical Center:
early stage non-small cell lung cancer
non-small cell lung cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases