RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
cancer cells from growing. Combining different types of biological therapies may kill more
PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery
and chemotherapy in treating patients who have stage II, stage III, or stage IV lung cancer.
- Evaluate the efficacy of immunotherapy with irradiated autologous tumor cell vaccine
plus sargramostim (GM-CSF) followed by monoclonal antibody OKT3- activated T
lymphocytes and interleukin-2 in combination with standard therapy in terms of response
rate in patients with stage II, III, or IV small cell or non-small cell lung cancer.
- Determine the immunogenicity of lung cancer in this patient population.
OUTLINE: Patients are stratified according to extent of disease, extent of antigen specific
response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.
Patients undergo surgical debulking of tumor on week 1 followed by adjuvant chemotherapy.
Within 2-4 weeks of chemotherapy, patients are vaccinated with irradiated autologous tumor
cells and sargramostim (GM-CSF), then receive GM-CSF alone intradermally at vaccination
sites daily for 4 days. Patients are revaccinated 2 weeks later.
Patients undergo peripheral blood mononuclear cell collection two weeks after the second
vaccination. Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal
antibody (OKT3) and interleukin-2, producing activated T lymphocytes. The activated T
lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every
other day over 10 days. Treatment continues in the absence of disease progression or
Patients may receive one additional course of immunotherapy as above.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
- Histologically proven stage II, III, or IV lung cancer
- Small cell and non-small cell disease eligible
- Resectable disease
- At least 50,000,000 viable cells obtained from surgical specimen for use in the
immunization part of this study
- 18 and over
- SWOG 0 or 1
- At least 6 months
- Granulocyte count at least 1,500/mm^3
- Platelet count at least lower limit of normal
- No active or recent uncontrolled bleeding
- Bilirubin normal
- SGOT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN
if liver metastases present)
- Creatinine normal
- Negative stool guaiac
- No impaired immunity
- No uncontrolled diabetes
- No active uncontrolled infections
- No other serious disease
- No other malignancies within the past 5 years except curatively treated basal or
squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- Not specified
- No concurrent chemotherapy
- Not specified
- Not specified
- See Disease Characteristics
- At least 2 weeks since prior therapy and recovered
Roy D. Baynes, MD, PhD, FACP
Barbara Ann Karmanos Cancer Institute