NCT00003974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 lung-cancer

Timeline
Completed

Started Aug 1997

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1997

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2000

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

August 20, 2004

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

10 months

First QC Date

November 1, 1999

Last Update Submit

March 3, 2011

Conditions

Lung CancerMalignant Mesothelioma

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerlocalized malignant mesotheliomastage IIIA non-small cell lung cancer

Interventions

lung tumor associated antigenBIOLOGICAL
DetoxPCDRUG
chemotherapyDRUG
cyclophosphamideDRUG

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsMesothelioma, MalignantCarcinoma, Non-Small-Cell Lung

Interventions

Drug TherapyCyclophosphamide

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesMesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialPleural NeoplasmsCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Timothy M. Anderson, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 20, 2004

Study Start

August 1, 1997

Primary Completion

June 1, 1998

Study Completion

November 1, 2000

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

US(1)