Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006216
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2000-09-11
Brief Title:
Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Malignant Pleural Mesothelioma With Gene Modified Cancer Cell Lines
Status:
UNKNOWN
Status Verified Date:
2001-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Ganciclovir may ease some of the side effects of cancer treatment Vaccines made from a persons 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LSUMC-3591 | None | None | None |
| NCI-V00-1604 | None | None | None |