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

August 21, 2017 updated by: Chandra P. Belani, Milton S. Hershey Medical Center

A Pilot Study of Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Patients With Resectable Non-Small Cell Lung Cancer

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.

Study Overview

Status

Withdrawn

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

Biological: Cyclin B1 Peptide

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

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria