Clinical trial NCT01909752: Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
Official title: Randomized Phase II Trial of Cyclophosphamide With Allogeneic Non-Small Cell Lung Cancer (NSCLC) DRibble Vaccine Alone or With Granulocyte-Macrophage Colony-Stimulating Factor or Imiquimod for Adjuvant Treatment of Definitively-Treated Stage IIIA or IIIB NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Lung cancer
DRibble Vaccine
Imiquimod
GM-CSF
HPV vaccine (Ceravix)
Cyclophosphamide
Lead sponsor: UbiVac
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
name: Providence Cancer Center, Earle A. Chiles Research Institute
name: Providence Health & Services
name: Mayo Clinic
name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2013-07-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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
* 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

Primary outcomes:
measure: Identify the regimen that produces the strongest antibody response
timeFrame: 95 days
Secondary outcomes:
measure: Safety
timeFrame: 43 weeks
measure: Progression free survival
timeFrame: 2 years
measure: Immune response and progression-free survival correlation.
timeFrame: 2 years
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU Stanley S. Scott Cancer Center
state: Louisiana
city: Portland
country: United States
facility: Providence Cancer Center
state: Oregon
Study officials:
affiliation: UbiVac
name: Bernard Fox, PhD
role: STUDY_DIRECTOR
References: