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An Evaluation of the Immunological Parameters Associated With a Skin-Test and Immunization of Lung and Mesothelioma Cancer Patients With Autologous Lung Tumor Associated Antigen: Characterization of the Patients' Cytolytic and Helper T Cell Reactivity for Identification of the Specific Antigen(s): A Pilot Study


Phase 1
20 Years
70 Years
Not Enrolling
Both
Lung Cancer, Malignant Mesothelioma

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Trial Information

An Evaluation of the Immunological Parameters Associated With a Skin-Test and Immunization of Lung and Mesothelioma Cancer Patients With Autologous Lung Tumor Associated Antigen: Characterization of the Patients' Cytolytic and Helper T Cell Reactivity for Identification of the Specific Antigen(s): A Pilot Study


OBJECTIVES: I. Define the immunological parameters of cytolytic T cell and T helper cell
activity associated with skin testing and vaccination with autologous lung tumor associated
antigen and detoxPC in patients with curatively resected stage I, II, or IIIA non-small cell
lung cancer (NSCLC) or stage I or II mesothelioma. II. Evaluate any responses associated
with an enhanced antitumor immune status in this patient population with this treatment
regimen.

OUTLINE: Patients undergo delayed type hypersensitivity skin testing with autologous tumor
associated antigen (TAA) and memory antigens (i.e., Monilia, PPD, and Trichophyton)
intradermally at 1-4 weeks following surgical tumor resection. At week 4-9, patients receive
low dose cyclophosphamide IV once. At 3 days following chemotherapy, patients receive
autologous TAA with DetoxPC intradermally for up to 3 doses over 4 weeks. At 2-3 weeks
following vaccination, patients undergo repeat skin testing. At week 6-12, patients with a
positive skin test undergo biopsy of the skin test/vaccination site followed by
leukapheresis at week 12-20 if T cells exhibit active antitumor reactivity. Patients with
stable or regressive disease receive additional vaccination courses at week 20 and
thereafter. Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven primary stage I (T2, N0), II, or IIIA
non-small cell lung cancer (NSCLC) curatively resected by pneumonectomy, lobectomy, or
wedge resection OR Stage I or II mesothelioma Measurable disease Lesions must be at least
3 cm in diameter

PATIENT CHARACTERISTICS: Age: 20 to 70 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: No other malignancy except nonmelanoma skin cancer No history of severe allergies
No history of autoimmune disease Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: No concurrent glucocorticoids Radiotherapy: Not specified Surgery: See
Disease Characteristics Other: No concurrent nonsteroidal antiinflammatory drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Timothy M. Anderson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067177

NCT ID:

NCT00003974

Start Date:

August 1997

Completion Date:

November 2000

Related Keywords:

  • Lung Cancer
  • Malignant Mesothelioma
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • localized malignant mesothelioma
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Mesothelioma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263