Treatment of Malignant Pleural Mesothelioma With Gene Modified Cancer Cell Lines
N/A
N/A
Both
Malignant Mesothelioma
Trial Information
Treatment of Malignant Pleural Mesothelioma With Gene Modified Cancer Cell Lines
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Paul O. Schwarzenberger, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Louisiana State University Health Sciences Center in New Orleans
Authority:
United States: Federal Government
Study ID:
CDR0000068049
NCT ID:
NCT00006216
Start Date:
August 1997
Completion Date:
Related Keywords:
- Malignant Mesothelioma
- stage IA malignant mesothelioma
- stage IB malignant mesothelioma
- stage II malignant mesothelioma
- stage III malignant mesothelioma
- Mesothelioma
Name | Location |
|---|---|
| Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
