Back to resultsA Novel Treatment for Metastatic Melanoma
Primary Purpose
Metastatic Melanoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Photoimmunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Melanoma focused on measuring metastatic melanoma
Eligibility Criteria
Inclusion Criteria:
- Age 18 and older
- Subjects must have Stage III or IV melanoma with histologically confirmed cutaneous metastatic malignant melanoma from any tumor site.
- Subjects must have measurable disease. See section 10.2 for the evaluation of measurable disease (RECIST).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Required laboratory parameters (all blood tests must be obtained within 14 days prior to the start of the study treatment):
Platelet count > 40,000 per mm3 Absolute Neutrophil Count (ANC) > 1,500 per mm3
Exclusion Criteria:
- Life expectancy, in the opinion of the investigator of less than 4 months
- Known allergy to any drugs used in treatment
- Immunosuppression, including HIV positive subjects, use of systemic steroids daily or other immunosuppressive medications within 1 month of treatment
- Chemotherapy/immunotherapy within 4 weeks of initiation
- Local chemotherapy or immunotherapy to target lesions with 4 weeks of initiation
- Radiation therapy at the treatment site within 4 weeks of initiation
- Uncontrolled brain metastases
- History of cutaneous photosensitization or photodermatoses
- Non-treated, active cancers other than melanoma and non-melanoma skin cancers.
- Active infectious disease requiring antibiotic therapy
- Unstable medical illness
- Past or present major psychiatric illness
- Pregnant or lactating women
- End stage renal disease or serum creatinine greater than the upper limit of normal or creatinine clearance <50cc/min
- Acute hepatitis (any cause)
Sites / Locations
- Northwestern University Feinberg School of Medicine, Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
Outcomes
Primary Outcome Measures
Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.
Secondary Outcome Measures
Assess time to disease progression
Evaluate tumor response by measuring clinically apparent tumors throughout study.
Quantify overall survival in this study population
Full Information
NCT ID
NCT00758797
First Posted
June 23, 2008
Last Updated
December 1, 2021
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00758797
Brief Title
A Novel Treatment for Metastatic Melanoma
Official Title
In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Study was not renewed during annual Northwestern Cancer Center review.
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.
Detailed Description
A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream with or without injection of a substance that makes the tumor more sensitive to the laser.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
metastatic melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
Intervention Type
Other
Intervention Name(s)
Photoimmunotherapy
Intervention Description
DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
Primary Outcome Measure Information:
Title
Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Assess time to disease progression
Time Frame
24 weeks to years
Title
Evaluate tumor response by measuring clinically apparent tumors throughout study.
Time Frame
24 weeks
Title
Quantify overall survival in this study population
Time Frame
years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 and older
Subjects must have Stage III or IV melanoma with histologically confirmed cutaneous metastatic malignant melanoma from any tumor site.
Subjects must have measurable disease. See section 10.2 for the evaluation of measurable disease (RECIST).
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Required laboratory parameters (all blood tests must be obtained within 14 days prior to the start of the study treatment):
Platelet count > 40,000 per mm3 Absolute Neutrophil Count (ANC) > 1,500 per mm3
Exclusion Criteria:
Life expectancy, in the opinion of the investigator of less than 4 months
Known allergy to any drugs used in treatment
Immunosuppression, including HIV positive subjects, use of systemic steroids daily or other immunosuppressive medications within 1 month of treatment
Chemotherapy/immunotherapy within 4 weeks of initiation
Local chemotherapy or immunotherapy to target lesions with 4 weeks of initiation
Radiation therapy at the treatment site within 4 weeks of initiation
Uncontrolled brain metastases
History of cutaneous photosensitization or photodermatoses
Non-treated, active cancers other than melanoma and non-melanoma skin cancers.
Active infectious disease requiring antibiotic therapy
Unstable medical illness
Past or present major psychiatric illness
Pregnant or lactating women
End stage renal disease or serum creatinine greater than the upper limit of normal or creatinine clearance <50cc/min
Acute hepatitis (any cause)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Novel Treatment for Metastatic Melanoma
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