Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004016
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
1999-11-01
Brief Title:
Interferon Gamma in Treating Patients With Recurrent or Metastatic Melanoma or Other Solid Tumors
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Phase I Trial of Immunotherapy With Adenovirus-Interferon- Gamma TG1041 in Patients With Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Interferon gamma may interfere with the growth of cancer cells and may be an effective treatment for melanoma and solid tumors
PURPOSE Phase I trial to study the effectiveness of interferon gamma in treating patients with recurrent or metastatic melanoma or other solid tumors
PURPOSE Phase I trial to study the effectiveness of interferon gamma in treating patients with recurrent or metastatic melanoma or other solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of intratumoral adenovirus vector containing interferon gamma in patients with locally recurrent or metastatic melanoma or other solid tumors II Assess the safety and tolerability of this regimen in this patient population III Determine the local or distant antitumor effect of this regimen in these patients IV Evaluate the biological and immunological effects of this regimen and the extent of local interferon gamma expression in these patients
OUTLINE This is a dose escalation study Patients receive adenovirus interferon gamma intratumorally on days 1 8 and 15 Patients achieving tumoral response may receive additional courses of therapy at the discretion of the investigator Cohorts of at least 3 patients receive escalating doses of adenovirus interferon gamma until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicity Patients are followed for 3 weeks after treatment
PROJECTED ACCRUAL A minimum of 12 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive adenovirus interferon gamma intratumorally on days 1 8 and 15 Patients achieving tumoral response may receive additional courses of therapy at the discretion of the investigator Cohorts of at least 3 patients receive escalating doses of adenovirus interferon gamma until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicity Patients are followed for 3 weeks after treatment
PROJECTED ACCRUAL A minimum of 12 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-G99-1559 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA011198 |
| P30CA011198 | NIH | None | None |
| URCC-U2698 | None | None | None |
| TRANSGENE-TG104101 | None | None | None |