Metastatic Malignant Melanoma and Renal Cell CarcinomaPhase 2NCT01925118
Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2
A Phase 2 study testing Irradiated donor lymphocyte infusion in people with Metastatic Malignant Melanoma and Renal Cell Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Malignant Melanoma and Renal Cell Carcinoma
- What is being tested?
- Irradiated donor lymphocyte infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to May 2015
- Phase
- Phase 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 malignant melanoma or renal cell carcinoma
- At stage IV or relapse
- At least one prior chemotherapy including targeted agents
- At least one haploidential or partially matched-HLA donor
- ECOG performance status 0-1
- Age 18-75 years
- Measurable lesion
- Adequate bone marrow, liver, and renal functions
Who cannot join
- Chemotherapy within 4 weeks
- Stem cell transplantation
- Active CNS metastasis
- Hypersensitivity to IL-2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma
Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.
- Being tested
- Irradiated donor lymphocyte infusion
- Medical subject headings
- Melanoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irradiated donor lymphocyte infusionBiological
| Study group | Role | What they receive |
|---|---|---|
| High-dose IL-2 | Experimental | Not described Receives: Biological: Irradiated donor lymphocyte infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-week modified immune-related response rate
Measured: 12-week
Secondary outcomes (5)
6-week modified immune-related response rate
Measured: 6-week
Overall response rate based on RECIST v1.1
Measured: 6/12-week
Progression-free survival
Measured: 6-month
Overall survival
Measured: 1-year
Immune-related adverse events
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Ineffectiveness
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Melanoma and Renal Cell CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae Seog Heo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925118
- Sponsor's protocol ID
- H-1305-6130491
- Status last verified
- Apr 2016
- First submitted
- 14 Aug 2013
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01925118
- Acronym / sponsor ID
- H-1305-6130491
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ineffectiveness
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Aug 2013 (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.
Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-dose IL-2 | Experimental | Biological: Irradiated donor lymphocyte infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed malignant melanoma or renal cell carcinoma
- At stage IV or relapse
- At least one prior chemotherapy including targeted agents
- At least one haploidential or partially matched-HLA donor
- ECOG performance status 0-1
Key exclusion criteria (4 listed)
- Chemotherapy within 4 weeks
- Stem cell transplantation
- Active CNS metastasis
- Hypersensitivity to IL-2
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 |
|---|---|---|
| Irradiated donor lymphocyte infusion | Biological | High-dose IL-2 |
Primary outcome
12-week modified immune-related response rate
Time frame: 12-week
5 secondary outcomes
6-week modified immune-related response rate
Time frame: 6-week
Overall response rate based on RECIST v1.1
Time frame: 6/12-week
Progression-free survival
Time frame: 6-month
Overall survival
Time frame: 1-year
Immune-related adverse events
Time frame: 12-week
Results and safety
The study was stopped early (reason given: Ineffectiveness). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
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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 2 study testing Irradiated donor lymphocyte infusion in people with Metastatic Malignant Melanoma and Renal Cell Carcinoma, 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Apr 2016. 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 phase mean?
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 was stopped early (reason given: Ineffectiveness). Results are not available in the source record.
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?
12-week modified immune-related response rate (time frame: 12-week). 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 Apr 2016; AzTrials last refreshed its copy on 1 Nov 2026.