Autologous Tumor DRibble Vaccine in Patients With Non-Small Cell Lung Cancer
This is a pilot single institution study of DRibble vaccination + GM-CSF in patients with stage IIIB or IV NSCLC who have undergone 0-1 chemotherapy regimens for metastatic disease. The primary objective of this trial is to evaluate immune responses induced by autologous DRibble vaccine in vivo and in vitro and against autologous and allogeneic lung cancer cells.
Checked against the public recordLast updated Sep 27, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Providence Health & Services
- Interventions being studied
- Biological: DRibble vaccine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Stage IIIB or IV NSCLC. * Adequate pleural effusion (\>600 cc) or subcutaneous metastases (\>1 cc) for * DRibble vaccine production. * Measurable or evaluable disease. * No or one prior chemotherapy regimen for advanced NSCLC. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Age \> 18 years. * CD4 count \> 200 per cc. * Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the toxicities that docetaxel may have on the forming fetus, spermatogenesis or the nursing child. * Also, because pregnancy may alter immune function it may limit the treatment efficacy. * Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy. Anticipated lifespan minimum 6 months. Exclusion Criteria: * Prior vaccine or gene therapy for cancer. * Untreated brain metastases or spinal cord compression. * Active autoimmune disease. * Active other malignancy. * Known hypersensitivity to docetaxel. * HIV positive and/or Hepatitis B or C positive. * Patients receiving any other concurrent investigational treatment. * Other medical or psychiatric conditions that in the opinion of the Principal * Investigator would preclude safe participation in protocol.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Providence Portland Medical CenterPortland, Oregon
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 27, 2016. Always confirm current availability with the study team.