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Autologous Tumor DRibble Vaccine in Patients With Non-Small Cell Lung Cancer

NCT00850785 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-09-27

No results posted yet for this study

Summary

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

BIOLOGICAL

DRibble vaccine

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).

Sponsors & Collaborators

  • The Wayne D. Kuni and Joan E. Kuni Foundation

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Walter J Urba, MD, PhD · Providence Health & Services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00850785 on ClinicalTrials.gov