A Pilot Study of Autologous Tumor DRibble Vaccine With Docetaxel in Stage IIIB and IV Non-Small Cell Lung Cancer
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
A Pilot Study of Autologous Tumor DRibble Vaccine With Docetaxel in Stage IIIB and IV Non-Small Cell Lung Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
DTH on days 7-10 and days 77-80 and blood for immune monitoring (30-50 cc) prior to each vaccine.
Safety Issue:
No
Principal Investigator
Walter J Urba, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Providence Health & Services
Authority:
United States: Food and Drug Administration
Study ID:
06-76
NCT ID:
NCT00850785
Start Date:
January 2009
Completion Date:
July 2014
Related Keywords:
- Non Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
