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CompletedPhase 1NCT00850785
Official study title

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

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDRibble vaccine

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 27, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Providence Health & Services

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Providence Health & Services
Interventions being studied
Biological: DRibble vaccine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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