Metastatic MelanomaPhase 1NCT00758797
A Novel Treatment for Metastatic Melanoma
A Phase 1 study testing Photoimmunotherapy in people with Metastatic Melanoma, run by Northwestern University at 1 site in United States.
Trial summary
A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Photoimmunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases
A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.
Read the 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.
- Conditions
- Metastatic Melanoma
- Being tested
- Photoimmunotherapy
- Keywords
- metastatic melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotoimmunotherapyOther
DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream Receives: Other: Photoimmunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.
Measured: 24 weeks
Secondary outcomes (3)
Assess time to disease progression
Measured: 24 weeks to years
Evaluate tumor response by measuring clinically apparent tumors throughout study.
Measured: 24 weeks
Quantify overall survival in this study population
Measured: years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Study was not renewed during annual Northwestern Cancer Center review.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758797
- Sponsor's protocol ID
- STU1213
- Status last verified
- Dec 2021
- First submitted
- 23 Jun 2008
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases
- ClinicalTrials.gov ID
- NCT00758797
- Acronym / sponsor ID
- STU1213
- Conditions
- Metastatic Melanoma
- Keywords
- metastatic melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was not renewed during annual Northwestern Cancer Center review.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: PhotoimmunotherapyDIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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):
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotoimmunotherapyDIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream | Other | 1 |
Primary outcome
Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.
Time frame: 24 weeks
3 secondary outcomes
Assess time to disease progression
Time frame: 24 weeks to years
Evaluate tumor response by measuring clinically apparent tumors throughout study.
Time frame: 24 weeks
Quantify overall survival in this study population
Time frame: years
Results and safety
The study was stopped early (reason given: Study was not renewed during annual Northwestern Cancer Center review.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Photoimmunotherapy in people with Metastatic Melanoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was not renewed during annual Northwestern Cancer Center review.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.