Lung Cancer Clinical Trial
Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
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.
Full 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
DRibbles vaccine, HPV vaccine, and GM-CSF After 11 patients have been assigned to each group, the study arm with the greatest number of vaccine-induced strong antibody responses will then continue with enrollment of 15 further patients. The primary objective is to determine the best strategy to induce strong (>15 fold) tumor-specific or tumor-associated antibody responses in patients with stage III A and B NSCLC. The goal is to select one regimen to advance to additional clinical trials.
Eligibility 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
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There are 2 Locations for this study
New Orleans Louisiana, 70112, United States
Portland Oregon, 97213, United States
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