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| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2000 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | August 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006216 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Malignant Mesothelioma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006216 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068049, LSUMC-3591, NCI-V00-1604 | ||||
| Study Sponsor ICMJE | Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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