Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
|ClinicalTrials.gov Identifier: NCT00006216|
Recruitment Status : Unknown
Verified July 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 26, 2004
Last Update Posted : September 20, 2013
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 or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Biological: PA-1-STK ovarian carcinoma vaccine Drug: ganciclovir||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Treatment of Malignant Pleural Mesothelioma With Gene Modified Cancer Cell Lines|
|Study Start Date :||August 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006216
|United States, Louisiana|
|Louisiana State University School of Medicine|
|New Orleans, Louisiana, United States, 70112-2822|
|Study Chair:||Paul O. Schwarzenberger, MD||Louisiana State University Health Sciences Center in New Orleans|