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Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma

This study is ongoing, but not recruiting participants.

Sponsored by: Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006216
  Purpose

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.


Condition Intervention Phase
Malignant Mesothelioma
Drug: PA-1-STK ovarian carcinoma vaccine
Drug: ganciclovir
Phase I

MedlinePlus related topics:   Cancer    Mesothelioma   

ChemIDplus related topics:   Ganciclovir    Ganciclovir sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Treatment of Malignant Pleural Mesothelioma With Gene Modified Cancer Cell Lines

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 1997

Detailed Description:

OBJECTIVES: I. Determine the safety and side effects of intrapleurally administered PA-1-STK modified ovarian carcinoma vaccine and ganciclovir in patients with stage I, II, or III malignant mesothelioma. II. Determine the maximum tolerated dose and dose limiting toxicities of this vaccine in these patients. III. Determine the immunologic response to this treatment regimen in these patients. IV. Determine the intrapleural pharmakokinetics of ganciclovir in these patients.

OUTLINE: This is a dose escalation study of PA-1-STK modified ovarian carcinoma vaccine. Patients receive PA-1-STK modified ovarian carcinoma vaccine intrapleurally on day 1 followed by ganciclovir IV over 1 hour for 7 days beginning on day 1. Patients in the first 2 cohorts receive 1 course of treatment only. In all subsequent cohorts, treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of PA-1-STK modified ovarian carcinoma vaccine until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 3-16 patients will be accrued for this study.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006216

Locations
United States, Louisiana
Louisiana State University School of Medicine    
      New Orleans, Louisiana, United States, 70112-2822

Sponsors and Collaborators
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

Investigators
Study Chair:     Paul O. Schwarzenberger, MD     Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068049, LSUMC-3591, NCI-V00-1604
First Received:   September 11, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006216
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma  
advanced malignant mesothelioma  
recurrent malignant mesothelioma  

Study placed in the following topic categories:
Mesothelioma
Ganciclovir
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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