MelanomaNCT02372708
Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy
An observational study of Melanoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and carry out monitoring on related immunological parameters of the patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma
- What is being tested?
- dinitrophenyl(DNP) and Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to May 2014
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma
Who may be able to join
- pathologically diagnosed as malignant melanoma, HMB45 (+～++++), S100 (+～++++);
- Basically normal hepatic and renal functions as well as results for blood routine examinations;
- Karnofsky score ≥ 60;
- Anticipated life span for more than three months;
- They were all malignant melanoma patients suffering from skin malignant melanoma of local or distal metastasis unsuitable for operations in their skin;
- The therapeutic efficacy was objectively evaluated with reference to the criteria from WHO;
- All of the subjects had signed the informed consent and had been submitted and approved by the ethic committee of the hospital, the compliance was good and follow-ups can be easily carried out.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100048
About this study
To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and carry out monitoring on related immunological parameters of the patients.
72 patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma were treated by combining simple semiantigen DNP in situ immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was observed, and results of clinical follow-ups were also examined.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dinitrophenyl(DNP)Drug
RadiationRadiation
laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2
| Study group | Role | What they receive |
|---|---|---|
| Experimental | diluted dinitrophenyl(DNP) Vaseline (which equaled to 2% DNP 0.1ml) was started to be directly spread on the surfaces of primary or metastatic tumors of malignant melanoma patients since the first day of every circle of chemotherapy, simultaneously laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2. The tumors were wrapped and blocked for two days to induce contact dermatitis. If lymph nodes had been cleared, sensibilization of 2×2cm was performed at occipital region. It was repeated once a week. Receives: Drug: dinitrophenyl(DNP); Radiation: Radiation | |
| Control | only diluted DNP Vaseline was spread and the operation were the same with the treatment group Receives: Drug: dinitrophenyl(DNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Patients who have complete regression or partial regression
Measured: 6 weeks after administration whose achieve CR and PR
Secondary outcomes (3)
PFS
Measured: From enrollment to progression or death, which up to 2 years
OS
Measured: From enrollment to death, which up to 2 years
biomarker (peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β)
peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β
Measured: day 0 and day 2,5,10,20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startAug 2008
- Primary completionMay 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DuNan, Chinese PLA General Hospital
- Investigators
- Nan Du, PHD, Principal investigator, First Affiliated Hospital, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372708
- Sponsor's protocol ID
- ML125396
- Status last verified
- Feb 2015
- First submitted
- 13 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy
- ClinicalTrials.gov ID
- NCT02372708
- Acronym / sponsor ID
- ML125396
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Feb 2015 (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.
To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and carry out monitoring on related immunological parameters of the patients.
72 patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma were treated by combining simple semiantigen DNP in situ immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was observed, and results of clinical follow-ups were also examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Drug: dinitrophenyl(DNP), Radiation: Radiationdiluted dinitrophenyl(DNP) Vaseline (which equaled to 2% DNP 0.1ml) was started to be directly spread on the surfaces of primary or metastatic tumors of malignant melanoma patients since the first day of every circle of chemotherapy, simultaneously laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2. The tumors were wrapped and blocked for two days to induce contact dermatitis. If lymph nodes had been cleared, sensibilization of 2×2cm was performed at occipital region. It was repeated once a week. |
| Control | – | Drug: dinitrophenyl(DNP)only diluted DNP Vaseline was spread and the operation were the same with the treatment group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma
Key inclusion criteria (7 listed)
- pathologically diagnosed as malignant melanoma, HMB45 (+～++++), S100 (+～++++);
- Basically normal hepatic and renal functions as well as results for blood routine examinations;
- Karnofsky score ≥ 60;
- Anticipated life span for more than three months;
- They were all malignant melanoma patients suffering from skin malignant melanoma of local or distal metastasis unsuitable for operations in their skin;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| dinitrophenyl(DNP) | Drug | Control, Experimental |
| Radiationlaser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2 | Radiation | Experimental |
Primary outcome
ORR
Time frame: 6 weeks after administration whose achieve CR and PR
Patients who have complete regression or partial regression
3 secondary outcomes
PFS
Time frame: From enrollment to progression or death, which up to 2 years
OS
Time frame: From enrollment to death, which up to 2 years
biomarker (peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β)
Time frame: day 0 and day 2,5,10,20
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 26 Feb 2015.
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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.
Nan Du, PHD principal investigator
First Affiliated Hospital, Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Chinese PLA General Hospital at 1 site in China.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 26 Feb 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 China. 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.
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?
ORR (time frame: 6 weeks after administration whose achieve CR and PR). 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 26 Feb 2015.