Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2013 |
| End Date: | December 2016 |
| Contact: | Brenda Fisher, RN |
| Email: | Brenda.Fisher@providence.org |
| Phone: | (503) 215-2613 |
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
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.
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.
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.
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.
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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