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

September 26, 2016 updated by: Providence Health & Services

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
DTH on days 7-10 and days 77-80 and blood for immune monitoring (30-50 cc) prior to each vaccine.

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response (RECIST criteria)
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence Health & Services

Collaborators

National Cancer Institute (NCI)
The Wayne D. Kuni and Joan E. Kuni Foundation

Investigators

  • Principal Investigator: Walter J Urba, MD, PhD, Providence Health & Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-76
  • 1R21CA123864-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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