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

NCT01398124 | Withdrawn DMC

• 1 other identifier: PSHCI 08-008
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Keywords

early stage non-small cell lung cancer; non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the ability of cyclin B1 peptide pulsed autologous dendritic cell vaccine to induce an immune response.

  One week after second vaccine

Interventions

Cyclin B1 Peptide BIOLOGICAL

vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chandra P. Belani, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 20, 2011
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 22, 2017

Record last verified: 2017-08