Status:
COMPLETED
Autologous Tumor DRibble Vaccine in Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
Providence Health & Services
Collaborating Sponsors:
The Wayne D. Kuni and Joan E. Kuni Foundation
National Cancer Institute (NCI)
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 object...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00850785
Start Date
January 1 2009
End Date
May 1 2012
Last Update
September 27 2016
Active Locations (1)
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1
Providence Portland Medical Center
Portland, Oregon, United States, 97213