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

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UbiVac
• Collaborators: Louisiana State University Health Sciences Center in New Orleans; Mayo Clinic; National Cancer Institute (NCI); Providence Cancer Center, Earle A. Chiles Research Institute; Providence Health & Services
• Treatments: Cyclophosphamide; Imiquimod; Vaccines

Criteria

Inclusion Criteria:

• Stage IIIA or IIIB histologically proven non-small cell lung cancer

• Completion of definitive therapy

• Enrollment from 28 days to 12 weeks from completion of definitive therapy

• Toxicities from definitive therapy resolved to less than grade 1

• ECOG performance status 0-1

• Negative pregnancy test in women of childbearing potential

• Agree to avoid pregnancy or fathering a child while on study treatment

• Ability to give informed consent and comply with protocol

• Anticipated survival minimum of 6 months

• Prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment

• Normal organ and marrow function as defined by specific lab tests

• Archived tumor tissue available

Exclusion Criteria:

• Active autoimmune disease except for vitilogo or hypothyroidism

• Active other malignancy

• Known HIV+ and/or Hepatitis B or C positive

• Medical or psychiatric conditions that would preclude safe participation

• Ongoing chemotherapy