Non Small Cell Lung Cancer Clinical Trial
— DRibbleOfficial title:
A Pilot Study of Autologous Tumor DRibble Vaccine With Docetaxel in Stage IIIB and IV 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.
Status | Completed |
Enrollment | 6 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Providence Portland Medical Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Providence Health & Services | National Cancer Institute (NCI), The Wayne D. Kuni and Joan E. Kuni Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaccine-induced immune response as measured by in vitro immune monitoring and by the delayed-type hypersensitivity (DTH) testing to injections of autologous, unmodified tumor cells and to DRibbles. | DTH on days 7-10 and days 77-80 and blood for immune monitoring (30-50 cc) prior to each vaccine. | No | |
Secondary | Tumor response (RECIST criteria) | Week 12 | No |
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