MelanomaPhase 1/2NCT03007823
High-activity Natural Killer Immunotherapy for Small Metastases of Melanoma
A Phase 1/2 study testing High-activity natural killer in people with Melanoma, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of melanoma. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Melanoma
- What is being tested?
- High-activity natural killer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 1 Jun 2019
- Phase
- Phase 1/2
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
- Body tumor 1-6, the maximum tumor length < 2 cm
- KPS ≥ 70, lifespan > 6 months
- Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Who cannot join
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
Fuda cancer institute of Fuda cancer hospital
Guangzhou, Guangdong, 510665
About this study
The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of melanoma.
Read the detailed description
By enrolling patients with small metastases of melanoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.
The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
- Conditions
- Melanoma
- Being tested
- High-activity natural killer
- Keywords
- Metastatic Melanoma, High-activity natural killer
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-activity natural killerBiological
Also called HANK cell
Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
| Study group | Role | What they receive |
|---|---|---|
| High-activity natural killer | Experimental | In this group, the patients will receive multiple high-activity natural killer (HANK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). Receives: Biological: High-activity natural killer |
| Control | No intervention | In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Measured: 3 months
Secondary outcomes (2)
Progress free survival（PFS）
Measured: 1 year
Overall survival（OS）
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start1 Dec 2016
- Primary completion1 Dec 2017
- Study completion1 Jun 2019
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hank Bioengineering Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007823
- Sponsor's protocol ID
- HANK-melanoma
- Status last verified
- Dec 2018
- First submitted
- 30 Dec 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-activity Natural Killer Immunotherapy for Small Metastases of Melanoma
- ClinicalTrials.gov ID
- NCT03007823
- Acronym / sponsor ID
- HANK-melanoma
- Conditions
- Melanoma
- Keywords
- Metastatic Melanoma, High-activity natural killer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Shenzhen Hank Bioengineering Institute
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 2 Jan 2017 (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.
The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of melanoma.
Detailed description
By enrolling patients with small metastases of melanoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.
The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-activity natural killer | Experimental | Biological: High-activity natural killerIn this group, the patients will receive multiple high-activity natural killer (HANK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
| Control | No intervention | –In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
- Body tumor 1-6, the maximum tumor length < 2 cm
- KPS ≥ 70, lifespan > 6 months
- Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Key exclusion criteria (3 listed)
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
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 |
|---|---|---|
| High-activity natural killerAlso: HANK cellEach treatment: 8-10 billion cells in all, transfuion in 3 times, i.v. | Biological | High-activity natural killer |
Primary outcome
Relief degree of tumors
Time frame: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
2 secondary outcomes
Progress free survival（PFS）
Time frame: 1 year
Overall survival（OS）
Time frame: 3 years
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 12 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing High-activity natural killer in people with Melanoma, run by Fuda Cancer Hospital, Guangzhou 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 4 inclusion and 3 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 12 Sep 2019. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Relief degree of tumors (time frame: 3 months). 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 12 Sep 2019.