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Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage IIIA Non-small Cell Lung Cancer or With Stage I or Stage II Mesothelioma

Brief Summary

RATIONALE: Vaccines made from a person's tumor may help the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have undergone surgery to remove stage I, stage II, or stage IIIA non-small cell lung cancer or stage I or stage II mesothelioma.

Tracking Information
First Received DateNovember 1, 1999
Last Changed DateMarch 3, 2011
Start DateAugust 1997
Actual Primary Completion DateJune 1998
Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Lung Cancer
  • Malignant Mesothelioma
Intervention
  • Biological: lung tumor associated antigen
  • Drug: DetoxPC
  • Drug: chemotherapy
  • Drug: cyclophosphamide
Detailed Description

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.

Recruitment Information
Recruitment StatusCompleted
Anticipated Enrollment20
GenderAll
Ages20 Years - 70 Years
Accepts Healthy VolunteersNo
Eligibility 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

Administrative Information
NCTIDNCT00003974
Responsible PartyTimothy M. Anderson, MD, Roswell Park Cancer Institute
SponsorRoswell Park Cancer Institute
Verification DateMarch 2011
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