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 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

August 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003974 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Lung Cancer
Malignant Mesothelioma

Intervention ^ICMJE

Biological: lung tumor associated antigen
Drug: DetoxPC
Drug: chemotherapy
Drug: cyclophosphamide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00003974

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067177, RPCI-DS-96-25, NCI-G99-1551

Study Sponsor ^ICMJE

Roswell Park Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Timothy M. Anderson, MD

Roswell Park Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP