NCT00850785

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

3.3 years

First QC Date

February 23, 2009

Last Update Submit

September 26, 2016

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Tumor response (RECIST criteria)

    Week 12

Interventions

DRibble vaccineBIOLOGICAL

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Related Publications (1)

  • Sanborn RE, Ross HJ, Aung S, Acheson A, Moudgil T, Puri S, Hilton T, Fisher B, Coffey T, Paustian C, Neuberger M, Walker E, Hu HM, Urba WJ, Fox BA. A pilot study of an autologous tumor-derived autophagosome vaccine with docetaxel in patients with stage IV non-small cell lung cancer. J Immunother Cancer. 2017 Dec 19;5(1):103. doi: 10.1186/s40425-017-0306-6.

    PMID: 29258618DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Walter J Urba, MD, PhD

    Providence Health & Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 27, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)