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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00850785
First Posted: February 25, 2009
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Wayne D. Kuni and Joan E. Kuni Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Providence Health & Services
  Purpose
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.

Condition Intervention Phase
Non Small Cell Lung Cancer Biological: DRibble vaccine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Autologous Tumor DRibble Vaccine With Docetaxel in Stage IIIB and IV Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • Tumor response (RECIST criteria) [ Time Frame: Week 12 ]

Enrollment: 6
Study Start Date: January 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850785


Locations
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
The Wayne D. Kuni and Joan E. Kuni Foundation
National Cancer Institute (NCI)
Investigators
Principal Investigator: Walter J Urba, MD, PhD Providence Health & Services
  More Information

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT00850785     History of Changes
Other Study ID Numbers: 06-76
1R21CA123864-01A2 ( U.S. NIH Grant/Contract )
First Submitted: February 23, 2009
First Posted: February 25, 2009
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vaccines
Docetaxel
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action