Brief Title
Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
Official Title
Treatment of Malignant Pleural Mesothelioma With Gene Modified Cancer Cell Lines
Brief Summary
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.
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Malignant Mesothelioma
Intervention
PA-1-STK ovarian carcinoma vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Start Date
August 1997
Eligibility 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Paul O. Schwarzenberger, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00006216
Organization ID
CDR0000068049
Secondary IDs
LSUMC-3591
Study Sponsor
Louisiana State University Health Sciences Center in New Orleans
Study Sponsor
Paul O. Schwarzenberger, MD, Study Chair, Louisiana State University Health Sciences Center in New Orleans
Verification Date
July 2001