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Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer

NCT01909752 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-07-06

No results posted yet for this study

Summary

This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.

BIOLOGICAL

DRibble vaccine

DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.

DRUG

Imiquimod

Imiquimod cream (5%, 250 mg containing 12.5 mg imiquimod - one packet/day) will be self applied once per day starting with the second vaccine (week 4). Immediately following vaccination and for four days following each vaccine cycle (total 5 days) imiquimod will be applied to a 4 x 5-cm outlined area of healthy extremity skin that includes the vaccine site.

DRUG

GM-CSF

GM-CSF will be administered at 50 mcg/day starting with the second vaccine (week 4) and continuing with each subsequent vaccine. A volume of 0.2 cc will be delivered by the CADD-MSTM 3 Ambulatory infusion pump at a rate of 0.008 cc/hr. The pump will be refilled after three days for a total of six days of infusion.

BIOLOGICAL

HPV vaccine

Immunization with HPV vaccine will consist of two 0.5-mL intramuscular injection at the time of the first and third vaccinations. The preferred site of administration is the deltoid region of the upper arm.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Providence Cancer Center, Earle A. Chiles Research Institute

    collaborator OTHER

  • Providence Health & Services

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER

  • UbiVac

    lead INDUSTRY

Principal Investigators

  • Bernard Fox, PhD · UbiVac

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-11-30
Completion
2017-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01909752 on ClinicalTrials.gov