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

Launched by UBIVAC · Jul 24, 2013

Keywords

ClinConnect Summary

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 II...

Gender

ALL

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