MelanomaPhase 1/2NCT00846833
Haploidentical NK Cell Infusion in Malignant Melanoma
A Phase 1/2 study testing Haploidentical NK cell in people with Melanoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
We hypothesized that haploidentical NK cells kill tumor cells more efficiently than autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study to investigate the role of haploidentical NK cell therapy in patients with refractory or relapsed malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Haploidentical NK cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Apr 2012
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic or relapsed malignant melanoma
- Patients who received prior chemotherapy or immunotherapy
- Patients who have at least one haploidentical donor willing to donate
- ECOG performance status 0 or 1
- 18 - 75 years
- At least one measurable disease according to the RECIST criteria
Show all 13Show fewer
- Patients with 45% or more left ventricular ejection fraction
- Patients with 50% or more predicted DLCO
- Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; and hemoglobin ≥ 9 g/dL
- Adequate liver function: total bilirubin ≤ 1.0 x upper limit of the normal range (ULN); AST/ALT ≤ 2.5 x ULN; and alkaline phosphatase ≤ 2.5 x ULN
- Adequate renal function: serum creatinine ≤ 1.0 x ULN or creatinine clearance ≥ 60 mL/min/1.73m2
- At least 3 months of expected survival
- Patients who signed informed consent
Who cannot join
- Patients who received other chemotherapeutic agents within 30 days prior to study enrollment
- Patients who received adoptive cell therapy including hematopoietic stem cell transplantation
- Patients infected with HIV, HBV, or HCV
- Hypersensitivity to cyclophosphamide or interleukin-2
- Patients who received organ transplantation
- Patients who had arrhythmia or ischemic heart disease
- Pregnant or lactating women
- Patients with uncontrolled infection who did not respond to appropriate antimicrobial agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of Haploidentical Natural Killer Cell Infusion in Patients With Refractory or Relapsed Malignant Melanoma
We hypothesized that haploidentical NK cells kill tumor cells more efficiently than autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study to investigate the role of haploidentical NK cell therapy in patients with refractory or relapsed malignant melanoma.
Read the detailed description
Human NK cells recognize and kill transformed cells in a MHC-unrestricted fashion, suggesting the role of cancer immunotherapy. However, autologous NK cells showed the lack of significant clinical effects, because they are inhibited by self MHC class I molecules, based on the missing-self hypothesis. Contrarily, haploidentical NK cells with KIR-ligand incompatibility can mediate graft-versus-leukemia effect and protect patients with acute myelogenous leukemia (AML) from graft-versus-host disease. In addition, adoptive transfer of haploidentical NK cells following high-intensity conditioning induced complete remission (26%) in poor-prognosis AML patients. Thus, this study was designed to investigate the role of adoptive NK cell therapy in patients with refractory or relapsed malignant melanoma using CD3+ depleting CliniMACS® system.
- Conditions
- Melanoma
- Being tested
- Haploidentical NK cell
- Keywords
- Melanoma, Experimental
- Medical subject headings
- Melanoma, Melanoma, Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haploidentical NK cellBiological
- Collection of PBMCs by leukapheresis
- CD3+ depletion of apheresis product using CliniMACS®
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide, high-dose interleukin-2, NK cell | Experimental | Not described Receives: Biological: Haploidentical NK cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum-tolerated dose of haploidentical NK cells
Measured: 1 year
Secondary outcomes (3)
To assess NK cell infusion-related toxicity
Measured: 2 years
To evaluate response rate
Measured: 2 years
To determine immune reconstitution after NK cell infusion
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionApr 2012
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 Seoul National University 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dae Seog Heo, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846833
- Sponsor's protocol ID
- H-0808-024-253
- Status last verified
- Jun 2012
- First submitted
- 17 Feb 2009
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Haploidentical Natural Killer Cell Infusion in Patients With Refractory or Relapsed Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00846833
- Acronym / sponsor ID
- H-0808-024-253
- Conditions
- Melanoma
- Keywords
- Melanoma, Experimental
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Feb 2009 (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.
We hypothesized that haploidentical NK cells kill tumor cells more efficiently than autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study to investigate the role of haploidentical NK cell therapy in patients with refractory or relapsed malignant melanoma.
Detailed description
Human NK cells recognize and kill transformed cells in a MHC-unrestricted fashion, suggesting the role of cancer immunotherapy. However, autologous NK cells showed the lack of significant clinical effects, because they are inhibited by self MHC class I molecules, based on the missing-self hypothesis. Contrarily, haploidentical NK cells with KIR-ligand incompatibility can mediate graft-versus-leukemia effect and protect patients with acute myelogenous leukemia (AML) from graft-versus-host disease. In addition, adoptive transfer of haploidentical NK cells following high-intensity conditioning induced complete remission (26%) in poor-prognosis AML patients. Thus, this study was designed to investigate the role of adoptive NK cell therapy in patients with refractory or relapsed malignant melanoma using CD3+ depleting CliniMACS® system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide, high-dose interleukin-2, NK cell | Experimental | Biological: Haploidentical NK cell |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed metastatic or relapsed malignant melanoma
- Patients who received prior chemotherapy or immunotherapy
- Patients who have at least one haploidentical donor willing to donate
- ECOG performance status 0 or 1
- 18 - 75 years
Key exclusion criteria (8 listed)
- Patients who received other chemotherapeutic agents within 30 days prior to study enrollment
- Patients who received adoptive cell therapy including hematopoietic stem cell transplantation
- Patients infected with HIV, HBV, or HCV
- Hypersensitivity to cyclophosphamide or interleukin-2
- Patients who received organ transplantation
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 |
|---|---|---|
| Haploidentical NK cell1. Collection of PBMCs by leukapheresis 2. CD3+ depletion of apheresis product using CliniMACS® | Biological | Cyclophosphamide, high-dose interleukin-2, NK cell |
Primary outcome
To determine the maximum-tolerated dose of haploidentical NK cells
Time frame: 1 year
3 secondary outcomes
To assess NK cell infusion-related toxicity
Time frame: 2 years
To evaluate response rate
Time frame: 2 years
To determine immune reconstitution after NK cell infusion
Time frame: 2 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 8 Jun 2012.
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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.
Dae Seog Heo, Professor principal investigator
Seoul National University Hospital
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 Haploidentical NK cell in people with Melanoma, run by Seoul National University Hospital at 1 site in South Korea.
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 13 inclusion and 8 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 8 Jun 2012. 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 South Korea. 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?
To determine the maximum-tolerated dose of haploidentical NK cells (time frame: 1 year). 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 8 Jun 2012.