Back to resultsImiquimod 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
Primary Purpose
Melanoma (Skin), Metastatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
imiquimod
indocyanine green solution
flow cytometry
immunologic technique
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, skin metastases
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma meeting the following criteria:
Stage III or IV disease
- Stage IV disease without observable, surgically unresectable metastases beyond the immediate treatment site allowed
Presence of 1 or more cutaneous metastases ≤ 3 cm in size
- Diffuse areas of tumor involvement can be used to qualify for the study if these areas involve primarily the epidermis and/or dermis and are less than 3 cm in thickness
No uncontrolled brain metastases
- Treated brain metastases that are stable for 3 months allowed at the investigator's discretion
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 4 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study completion
- No known allergy to any drugs used during study treatment
- No unstable medical illness
Not immunosuppressed
- Patients immunosuppressed due to disease (e.g., HIV positive) allowed
PRIOR CONCURRENT THERAPY:
- No systemic steroids or any other immunosuppressive medications within the past month
- No chemotherapy within the past 4 weeks
No radiotherapy to the treatment site within the past 4 weeks
- Palliative radiotherapy to sites other than cutaneous treatment and assessment sites allowed
- No concurrent immunosuppressive agents
Sites / Locations
- Oklahoma University Cancer Institute
Outcomes
Primary Outcome Measures
Toxicity and tolerability by CTCAE version 3.0
Complete systemic and local response rates at 16 months
Secondary Outcome Measures
Immunologic parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00453050
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
Official Title
Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oklahoma
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Metastatic Cancer
Keywords
stage III melanoma, stage IV melanoma, skin metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
imiquimod
Intervention Type
Drug
Intervention Name(s)
indocyanine green solution
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Other
Intervention Name(s)
immunologic technique
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Toxicity and tolerability by CTCAE version 3.0
Title
Complete systemic and local response rates at 16 months
Secondary Outcome Measure Information:
Title
Immunologic parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma meeting the following criteria:
Stage III or IV disease
Stage IV disease without observable, surgically unresectable metastases beyond the immediate treatment site allowed
Presence of 1 or more cutaneous metastases ≤ 3 cm in size
Diffuse areas of tumor involvement can be used to qualify for the study if these areas involve primarily the epidermis and/or dermis and are less than 3 cm in thickness
No uncontrolled brain metastases
Treated brain metastases that are stable for 3 months allowed at the investigator's discretion
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy ≥ 4 months
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after study completion
No known allergy to any drugs used during study treatment
No unstable medical illness
Not immunosuppressed
Patients immunosuppressed due to disease (e.g., HIV positive) allowed
PRIOR CONCURRENT THERAPY:
No systemic steroids or any other immunosuppressive medications within the past month
No chemotherapy within the past 4 weeks
No radiotherapy to the treatment site within the past 4 weeks
Palliative radiotherapy to sites other than cutaneous treatment and assessment sites allowed
No concurrent immunosuppressive agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Naylor, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Study Chair
Facility Information:
Facility Name
Oklahoma University Cancer Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135-2512
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20890121
Citation
Li X, Naylor MF, Le H, Nordquist RE, Teague TK, Howard CA, Murray C, Chen WR. Clinical effects of in situ photoimmunotherapy on late-stage melanoma patients: a preliminary study. Cancer Biol Ther. 2010 Dec 1;10(11):1081-7. doi: 10.4161/cbt.10.11.13434. Epub 2010 Dec 1.
Results Reference
background
PubMed Identifier
17107404
Citation
Naylor MF, Chen WR, Teague TK, Perry LA, Nordquist RE. In situ photoimmunotherapy: a tumour-directed treatment for melanoma. Br J Dermatol. 2006 Dec;155(6):1287-92. doi: 10.1111/j.1365-2133.2006.07514.x.
Results Reference
background
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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
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