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Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma Clinical research trials and Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma. Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma clinical trial. Participants typically obtain the most effective healthcare available for their Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma  Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
For Condition: localized malignant mesothelioma,childhood thorax/respiratory cancer,recurrent malignant mesothelioma,advanced malignant mesothelioma
Status: No longer recruiting
Sponsor(s): Louisiana State University ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulSchwarzenberger, Study Chair, Louisiana State University
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112-2822
United States
Additional Information:
Study ID Numbers: CDR0000068049; LSUMC-3591,NCI-V00-1604
Study Start Date: August 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006216
Other Childhood Thorax/respiratory Cancer Studies:
1. Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
2. Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
3. Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma
4. PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
5. Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
Related Studies:
Other childhood thorax/respiratory cancer Clinical Trials
Other Louisiana Clinical Trials
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Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
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