Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma - Full Text View

Sponsor:	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	Biological: PA-1-STK ovarian carcinoma vaccine Drug: ganciclovir	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Ganciclovir Ganciclovir sodium

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000068049, LSUMC-3591, NCI-V00-1604
Study First Received:	September 11, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006216 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Therapeutic Uses
Mesothelioma

Ganciclovir
Antiviral Agents
Adenoma
Pharmacologic Actions
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009