Status:
COMPLETED
Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
Lead Sponsor:
UbiVac
Collaborating Sponsors:
National Cancer Institute (NCI)
Providence Cancer Center, Earle A. Chiles Research Institute
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
This is an open-label, randomized study in which the first 33 patients will be assigned to receive the either: * DRibbles vaccine and HPV vaccine * DRibbles vaccine, HPV vaccine, and imiquimod * DRib...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01909752
Start Date
July 1 2013
End Date
April 1 2017
Last Update
July 6 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
LSU Stanley S. Scott Cancer Center
New Orleans, Louisiana, United States, 70112
2
Providence Cancer Center
Portland, Oregon, United States, 97213