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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Wayne D. Kuni and Joan E. Kuni Foundation
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00850785
First received: February 23, 2009
Last updated: January 7, 2013
Last verified: January 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response (RECIST criteria) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Walter J Urba, MD, PhD Providence Health & Services
  More Information

No publications provided

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT00850785     History of Changes
Other Study ID Numbers: 06-76, 1R21CA123864-01A2
Study First Received: February 23, 2009
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014