NCT00006216

Brief Summary

RATIONALE: Ganciclovir may ease some of the side effects of cancer treatment. Vaccines made from a person's modified malignant mesothelioma cells may make the cancer more sensitive to ganciclovir. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus ganciclovir in treating patients who have stage I, stage II, or stage III malignant mesothelioma.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1997

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

April 26, 2004

Completed
Last Updated

September 20, 2013

Status Verified

July 1, 2001

First QC Date

September 11, 2000

Last Update Submit

September 19, 2013

Conditions

Malignant Mesothelioma

Keywords

stage IA malignant mesotheliomastage IB malignant mesotheliomastage II malignant mesotheliomastage III malignant mesothelioma

Interventions

PA-1-STK ovarian carcinoma vaccineBIOLOGICAL
ganciclovirDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed stage I, II, or III malignant mesothelioma Must have adequate pleural space in which to place chest tube or catheter PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hematocrit greater than 30% WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT and alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.5 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: No significant history of heart disease No frequent angina No myocardial infarction within the past 6 months No congestive heart failure requiring daily treatment Pulmonary: No evidence of moderate to severe pulmonary disease (i.e., FEV1 less than 40% predicted) Other: No prior malignancy except squamous or basal cell carcinoma of the skin No patients with childbearing potential PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior chemotherapy Endocrine therapy: No concurrent steroid treatment Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112-2822, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Paul O. Schwarzenberger, MD

    Louisiana State University Health Sciences Center in New Orleans

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2000

First Posted

April 26, 2004

Study Start

August 1, 1997

Last Updated

September 20, 2013

Record last verified: 2001-07

Locations

US(1)