Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003856
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Photodynamic Therapy in Treating Patients With Recurrent Refractory or Second Primary Head and Neck Cancer That Cannot Be Treated With Surgery or Radiation Therapy
Sponsor:
Quintiles Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Multi-National Open-Label Single Group Single and Multiple Dose Study of Foscan-Mediated Photodynamic Therapy PDT for the Palliative Treatment of Recurrent Refractory or Second Primary Squamous Cell Carcinomas of the Head and Neck in Patients Considered to be Incurable With Surgery or Radiotherapy
Status:
UNKNOWN
Status Verified Date:
2001-01
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 Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells This may be an effective palliative treatment for head and neck cancer
PURPOSE Phase II trial to study the effectiveness of photodynamic therapy for palliative treatment in patients who have recurrent refractory or second primary head and neck cancer that cannot be treated with surgery or radiation therapy
PURPOSE Phase II trial to study the effectiveness of photodynamic therapy for palliative treatment in patients who have recurrent refractory or second primary head and neck cancer that cannot be treated with surgery or radiation therapy
Detailed Description:
OBJECTIVES I Determine the individual clinical benefit of temoporfin-mediated photodynamic therapy for palliative treatment in patients with recurrent refractory or second primary squamous cell cancer of the head and neck II Determine the improvement in global functional and symptomatic measures of quality of life in these patients III Determine the toxic effects tolerability and safety of this regimen in these patients IV Determine the population pharmacokinetics objective tumor response complete and partial and the 1 year survival of these patients on this regimen
OUTLINE This is a multicenter study Patients receive IV temoporfin on day -4 followed by laser light therapy on day 0 Patients are treated every 4 to 16 weeks for a maximum of 3 courses Patients are evaluated on days 1 2 7 and weeks 2 4 6 8 12 and 16 following laser light therapy Quality of life is assessed at baseline through week 12 of follow-up Patients are followed monthly for 4 months after the final treatment then every 3 months for 1 year
PROJECTED ACCRUAL A minimum of 50 prospective and 25 retrospective patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive IV temoporfin on day -4 followed by laser light therapy on day 0 Patients are treated every 4 to 16 weeks for a maximum of 3 courses Patients are evaluated on days 1 2 7 and weeks 2 4 6 8 12 and 16 following laser light therapy Quality of life is assessed at baseline through week 12 of follow-up Patients are followed monthly for 4 months after the final treatment then every 3 months for 1 year
PROJECTED ACCRUAL A minimum of 50 prospective and 25 retrospective 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-V99-1539 | None | None | None |
| QUINT-00900308b | None | None | None |
| SCOTIA-QUINT-00900308b | None | None | None |