- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03007823
High-activity Natural Killer Immunotherapy for Small Metastases of Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510665
- Fuda cancer institute of Fuda cancer hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with cardiac pacemaker
- Patients with brain metastasis
- Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: High-activity natural killer
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).
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Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
Other Names:
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NO_INTERVENTION: Control
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relief degree of tumors
Time Frame: 3 months
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It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Progress free survival(PFS)
Time Frame: 1 year
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1 year
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Overall survival(OS)
Time Frame: 3 years
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3 years
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HANK-melanoma
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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