Malignant Mesothelioma Clinical Trial
Official title:
Treatment of Malignant Pleural Mesothelioma With Gene Modified Cancer Cell Lines
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.
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.
;
Primary Purpose: Treatment
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