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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Information provided by (Responsible Party):
Chandra P. Belani, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01398124
First received: July 19, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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 Intervention
Non-small Cell Lung Cancer
Biological: Cyclin B1 Peptide

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

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 ]

Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
vaccine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398124

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

No publications provided

Responsible Party: Chandra P. Belani, Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01398124     History of Changes
Other Study ID Numbers: PSHCI 08-008
Study First Received: July 19, 2011
Last Updated: January 8, 2013
Health Authority: 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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014