Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007969
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2001-01-06
Brief Title:
Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
QLT Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 12 Uncontrolled Open Label Study Of Photodynamic Vaccination In Patients With Stage IIIIV Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2008-08
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 Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells Photodynamic therapy may be effective in treating melanoma
PURPOSE Phase III trial to study the effectiveness of photodynamic therapy in treating patients who have stage III or stage IV melanoma
PURPOSE Phase III trial to study the effectiveness of photodynamic therapy in treating patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES I Determine the safety of photodynamic therapy with verteporfin and Detox-B adjuvant in patients with stage III or IV melanoma II Determine the clinical response in patients treated with this regimen III Determine whether this regimen induces systemic cellular and humoral immune responses to melanoma antigens in these patients IV Determine the ablation of cutaneous tumors in patients treated with this regimen
OUTLINE This is a multicenter study Patients undergo photodynamic therapy with verteporfin and Detox-B adjuvant Treatment repeats every 2 weeks for a total of 3 courses each to a different melanoma lesion Both non-treated and treated tumors are measured prior to study and at months 2 4 and 6 Immune profile is also assessed prior to study and at months 2 4 and 6
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 12 months
OUTLINE This is a multicenter study Patients undergo photodynamic therapy with verteporfin and Detox-B adjuvant Treatment repeats every 2 weeks for a total of 3 courses each to a different melanoma lesion Both non-treated and treated tumors are measured prior to study and at months 2 4 and 6 Immune profile is also assessed prior to study and at months 2 4 and 6
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| QLT-PHO-VFI-PDV-01 | None | None | None |
| QLT-VFI-PDV-01 | None | None | None |