Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-28 @ 1:47 AM
Study NCT ID:
NCT00453050
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2007-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin
Sponsor:
University of Oklahoma
Organization:
Study Overview
Official Title:
Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study
Status:
COMPLETED
Status Verified Date:
2008-11
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: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Laser therapy uses light to kill tumor cells. Giving imiquimod together with laser therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with or without a green dye in treating patients with stage III or stage IV melanoma that has spread to other parts of the skin.
PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with or without a green dye in treating patients with stage III or stage IV melanoma that has spread to other parts of the skin.
Detailed Description:
OBJECTIVES:
Primary
* Determine the toxicity of in situ photoimmunotherapy comprising imiquimod and infrared laser therapy with or without indocyanine green in patients with stage III or IV melanoma and cutaneous metastases.
* Determine the complete systemic and local response rates in patients treated with this regimen.
Secondary
* Determine the effect of this treatment on immunologic parameters in these patients.
OUTLINE: This is a prospective, open-label, pilot study.
Patients undergo in situ photoimmunotherapy (ISPI) comprising topical imiquimod twice daily on days 1-42 and infrared laser therapy (with or without indocyanine green) on days 14 and 28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Blood is collected at baseline, prior to ISPI, 24 hours after ISPI, and at week 6. Samples are examined for cytokine response, CD8 T-cell activation and regulatory T-cell assays (by flow cytometry), and antibody response (by western blot).
After completion of study treatment, patients are followed monthly for 3 months and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Primary
* Determine the toxicity of in situ photoimmunotherapy comprising imiquimod and infrared laser therapy with or without indocyanine green in patients with stage III or IV melanoma and cutaneous metastases.
* Determine the complete systemic and local response rates in patients treated with this regimen.
Secondary
* Determine the effect of this treatment on immunologic parameters in these patients.
OUTLINE: This is a prospective, open-label, pilot study.
Patients undergo in situ photoimmunotherapy (ISPI) comprising topical imiquimod twice daily on days 1-42 and infrared laser therapy (with or without indocyanine green) on days 14 and 28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Blood is collected at baseline, prior to ISPI, 24 hours after ISPI, and at week 6. Samples are examined for cytokine response, CD8 T-cell activation and regulatory T-cell assays (by flow cytometry), and antibody response (by western blot).
After completion of study treatment, patients are followed monthly for 3 months and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: