Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005057
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2000-04-06
Brief Title:
Gene Therapy and Ganciclovir in Treating Patients With Stage IV Melanoma
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Intralesional Administration of an Adenovirus Vector Expressing the HSV-1 Thymidine Kinase Gene AdVRSV-TK in Combination With Escalating Doses of Ganciclovir in Patients With Cutaneous Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2002-12
Last Known Status:
None
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 Inserting a modified herpesvirus gene into a persons melanoma cells may make the cancer more sensitive to the antiviral agent ganciclovir
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have stage IV melanoma
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have stage IV melanoma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of ganciclovir administered IV every 12 hours for 7 days in combination with adenovirus RSV-TK administered by direct intralesional injection in patients with cutaneous or subcutaneous metastatic malignant melanoma II Determine the dose limiting toxicities of this regimen in this patient population III Evaluate the response both local and at distant metastatic sites duration of response response by ganciclovir dose and any impact local treatment with adenovirus RSV-TK and ganciclovir suicide gene therapy may have on overall survival in these patients
OUTLINE This is a dose escalation study of ganciclovir Patients are stratified according to response of the index lesion and other metastatic disease sites Patients receive an intratumoral injection of adenovirus RSV-TK on day 1 Ganciclovir IV is administered every 12 hours on days 3-10 for a total of 14 doses Patients sustaining a partial response PR or complete response CR may be retreated 2 weeks after documented PR or CR Cohorts of 3-6 patients receive escalating doses of ganciclovir until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Patients are followed at 3 weeks 4 weeks 60 days then every 2 months for 6 months and then every 3 months for 15 years
PROJECTED ACCRUAL A maximum of 27 patients will be accrued for this study
OUTLINE This is a dose escalation study of ganciclovir Patients are stratified according to response of the index lesion and other metastatic disease sites Patients receive an intratumoral injection of adenovirus RSV-TK on day 1 Ganciclovir IV is administered every 12 hours on days 3-10 for a total of 14 doses Patients sustaining a partial response PR or complete response CR may be retreated 2 weeks after documented PR or CR Cohorts of 3-6 patients receive escalating doses of ganciclovir until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Patients are followed at 3 weeks 4 weeks 60 days then every 2 months for 6 months and then every 3 months for 15 years
PROJECTED ACCRUAL A maximum of 27 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 |
|---|---|---|---|
| NCI-98-C-0140C | None | None | None |