Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Resectable Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398124
Recruitment Status : Withdrawn (We will not be pursuing this study.)
First Posted : July 20, 2011
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Chandra P. Belani, Milton S. Hershey Medical Center

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 (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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: Cyclin B1 Peptide Not Applicable

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Patients With Resectable Non-Small Cell Lung Cancer
Study Start Date : December 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Intervention Details:
  • Biological: Cyclin B1 Peptide

Primary Outcome Measures :
  1. Evaluate the ability of cyclin B1 peptide pulsed autologous dendritic cell vaccine to induce an immune response. [ Time Frame: One week after second vaccine ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01398124

Sponsors and Collaborators
Milton S. Hershey Medical Center
Principal Investigator: Chandra P. Belani, MD Milton S. Hershey Medical Center

Responsible Party: Chandra P. Belani, Professor of Medicine, Milton S. Hershey Medical Center Identifier: NCT01398124     History of Changes
Other Study ID Numbers: PSHCI 08-008
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Chandra P. Belani, Milton S. Hershey Medical Center:
early stage non-small cell lung cancer
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immunologic Factors
Physiological Effects of Drugs