Melanoma (Skin)Phase 1NCT00453050
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
A Phase 1 study testing imiquimod, indocyanine green solution and flow cytometry in people with Melanoma (Skin) and Metastatic Cancer, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Metastatic Cancer
- What is being tested?
- imiquimod, indocyanine green solution and flow cytometry
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2009
- 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
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma University Cancer Institute
Tulsa, Oklahoma, 74135-2512
About this study
Official title: Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study
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.
Read the 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.
- Conditions
- Melanoma (Skin), Metastatic Cancer
- Being tested
- imiquimod, indocyanine green solution, flow cytometry, immunologic technique, laboratory biomarker analysis
- Keywords
- stage III melanoma, stage IV melanoma, skin metastases
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imiquimodDrug
indocyanine green solutionDrug
flow cytometryOther
immunologic techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity and tolerability by CTCAE version 3.0
Complete systemic and local response rates at 16 months
Secondary outcomes (1)
Immunologic parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startMar 2006
- Primary completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Investigators
- Mark Naylor, MD, Study chair, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453050
- Sponsor's protocol ID
- CDR0000536471
- Other IDs
- OU-12576, OU-ISPI
- Status last verified
- Nov 2008
- First submitted
- 27 Mar 2007
- Last updated
- 6 May 2015
- Results posted
- No
Publications
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.
PubMed 20890121Naylor 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.
PubMed 17107404
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study
- ClinicalTrials.gov ID
- NCT00453050
- Acronym / sponsor ID
- CDR0000536471
- Conditions
- Melanoma (Skin), Metastatic Cancer
- Keywords
- stage III melanoma, stage IV melanoma, skin metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2009 (actual)
- First posted
- 28 Mar 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| imiquimod | Drug | – |
| indocyanine green solution | Drug | – |
| flow cytometry | Other | – |
| immunologic technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Toxicity and tolerability by CTCAE version 3.0
Complete systemic and local response rates at 16 months
1 secondary outcome
Immunologic parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Background: PubMed 20890121Li 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.
- Background: PubMed 17107404Naylor 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.
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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.
Mark Naylor, MD study chair
University of Oklahoma
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 imiquimod, indocyanine green solution and flow cytometry in people with Melanoma (Skin) and Metastatic Cancer, run by University of Oklahoma 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?
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: finished, as of the sponsor's last update on 6 May 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Toxicity and tolerability by CTCAE version 3.0. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453050, which also lists 2 linked publications.
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 6 May 2015.