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Immunotherapy for Lung Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Immunotherapy for Lung Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy


OBJECTIVES:

- 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
unacceptable toxicity.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- SWOG 0 or 1

Life expectancy:

- At least 6 months

Hematopoietic:

- Granulocyte count at least 1,500/mm^3

- Platelet count at least lower limit of normal

- No active or recent uncontrolled bleeding

Hepatic:

- Bilirubin normal

- SGOT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN
if liver metastases present)

Renal:

- Creatinine normal

Other:

- 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:

Biologic therapy:

- Not specified

Chemotherapy:

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Other:

- At least 2 weeks since prior therapy and recovered

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Roy D. Baynes, MD, PhD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067238

NCT ID:

NCT00004019

Start Date:

June 1997

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • limited stage small cell lung cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Lung Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201