A Phase 1 interventional study of DRibble vaccine in Non Small Cell Lung Cancer, sponsored by Providence Health & Services. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-27.
Sponsored by Providence Health & Services · Phase 1, Interventional, and Treatment
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.
Ten patients will be enrolled. Study treatment is as follows: Docetaxel 75 mg/m2 will be given on day 1. Intradermal vaccinations of DRibbles from 5-20 x 106 cell equivalents per vaccine will begin 14 days after docetaxel. Immediately following vaccination, subcutaneous infusion of GM-CSF (50 micrograms/24 hrs) will be initiated. GM-CSF will be infused into the vaccination site for 6 days using the CADD-MS 3 pump.
A second docetaxel injection will be given at day 29 followed by a second vaccination 14 days later and 3 additional vaccines will be given at 2-week intervals. Following each vaccination, GM-CSF will again be infused over 6 days via the CADD-MS 3 pump.
Peripheral blood will be obtained for immune monitoring at each vaccination. DTH to autologous tumor and to DRibble vaccine will be tested before the first and fifth vaccines. A second leukapheresis for immune monitoring will be obtained at 12 weeks. Clinical tumor response will be assessed after the fifth vaccination unless clinical evidence of tumor progression occurs sooner.
Immune response will be assessed by DTH, T-cell function, T-cell migration into the vaccine sites and cytokine release assays. Sophisticated flow cytometry assays will be used to detect active T-cell subsets. Safety will be monitored by physical and laboratory exams at each vaccine visit and adverse events will be recorded and reported as appropriate. Clinical response will be assessed by tumor measurements by CT scan and/or physical exam at study entry and after 12 weeks. PFS and OS will be recorded.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 6 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Providence Health & Services is the lead sponsor of 84 studies on the registry; 6 are open to participants now.
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Anticipated lifespan minimum 6 months.
Exclusion Criteria:
Docetaxel 75 mg/m2 will be administered in the several days after leukapheresis. Intradermal (ID) vaccine injections of DRibbles made from at least 5 million and up to 20 million cell equivalents per vaccination will begin 14 days after the first docetaxel. Each DRibble vaccine will be followed by the 6-day infusion of GM-CSF via the CADD-MS 3 pump (50 micrograms/24 hrs).
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.
Time frame: DTH on days 7-10 and days 77-80 and blood for immune monitoring (30-50 cc) prior to each vaccine.
Tumor response (RECIST criteria)
Time frame: Week 12
Plan to share: No
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Providence Health & Services