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Combination Immunotherapy for Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Combination Immunotherapy for Lung Cancer

This protocol describes a phase II study involving patients with stage IV adenocarcinoma of
the lung. Treatment will consist of Cyclophosphamide (300 mg/m²) to be given IV on day 1 and
day 57. On day 4 immunization with intradermal vaccine injections at 4 separate sites
(bilateral upper arms and bilateral upper thighs will be repeated every 14 days times 2
followed by every 28 days times 3 (day 4, 18, 32, 60, 88, and 116). Decavac (tetanus shot)
0.5 cc intramuscular (IM) will be given after the first vaccine. ATRA (150 mg/m2/day) oral
three times daily (TID) dosing administered after the first and fourth vaccines (day 5-7 &
day 61-63). Those patients achieving stable disease (SD), partial response (PR), or complete
response (CR) at restaging after the initial 6 vaccines will receive additional vaccines
every 3 months until disease progression. The vaccine will consist of GM.CD40L bystander
cells admixed with an equivalent number of the 2 allogeneic tumor cell lines. There will be
a +/- 7 day window for all study related exams, tests, and procedures.

Inclusion Criteria:

- Histologically confirmed metastatic adenocarcinoma of the lung

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1

- No radiation therapy within 2 weeks of first vaccine administration

- No chemotherapy within 4 weeks of first vaccine administration

- No steroid therapy within 4 weeks of first vaccine administration

- Patient's written informed consent

- Adequate organ function (measured within a week of beginning treatment)

- Patients will be tested for human leukocyte antigen A0201 (HLA-A0201) as determined
by flow cytometry followed by molecular analysis of a peripheral blood specimen,
however this result will not be an inclusion criterion.

- Measurable metastatic tumor as defined by standard Response Evaluation Criteria In
Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one
dimension with the longest diameter greater than or equal 20mm. With spiral computer
tomography (CT) scan, lesion must be greater than or equal to 10 mm at least one

- Patient's must have received, and completed first line chemotherapy.

Exclusion Criteria:

- Symptomatic brain metastasis

- Any acute medical problems requiring active intervention

- Current corticosteroid (other than replacement doses in patients who are hypoadrenal)
or other immunosuppressive therapy

- Any other pre-existing immunodeficiency condition (including known HIV infection)

- Pregnant or lactating women -- Patients in reproductive age must agree to use
contraceptive methods for the duration of the study (*A pregnancy test will be
obtained before treatment).

- Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3 or 4

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Evaluable Participants With Tumor Response

Outcome Description:

Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Alberto Chiappori, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

June 2012

Related Keywords:

  • Lung Cancer
  • adenocarcinoma of the lung
  • stage IV non-small cell lung cancer
  • Lung Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612