Metastatic MelanomaPhase 2SBRT/IL-2NCT01416831
Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma.
A Phase 2 study testing Radiation therapy and high-dose IL-2 and High-dose IL-2 in people with Metastatic Melanoma, run by Providence Health & Services at 1 site in United States.
Trial summary
The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Radiation therapy and high-dose IL-2 and High-dose IL-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2011to Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of melanoma will be required by previous biopsy or cytology.
- Patients must be ≥ 18 years of age.
- Patients must have tumors amenable to SBRT in lungs, mediastinum, chest wall, bones (other than long bones), or liver (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. Patients may have other metastases but only a maximum of 3 will be treated.
- ECOG performance status of 0-1.
- Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
- Patients must sign a study-specific consent form.
Who cannot join
- No metastatic site amenable to SBRT.
- Patients with brain metastases not candidates for radiosurgery.
- Previous radiation to sites proposed for radiation as part of this study.
- Patients with active systemic, pulmonary, or pericardial infection.
- Pregnant or lactating women.
- Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG.
Show all 13Show fewer
- DLCO, FEV1 or FEV1/FVC less than 70% of predicted due to clinically significant underlying pulmonary disease. For any pulmonary function test values less than predicted values, the PI will review, and document the patient's suitability for high dose IL-2 therapy.
- WBC < 3.0 x 109/L
- Hgb < 9.0 g/dL
- AST/ALT > 3 times the upper limit of the normal range
- total bilirubin > 1.9 g/dL
- creatinine > 1.9 g/dL
- Patient requires chronic steroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Melanoma
The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation therapy.
Read the detailed description
All patients will receive high-dose IL-2. Half the patients enrolled will be randomly selected to receive radiation therapy to up to three tumors prior to receiving high-dose IL-2. Among the first 20 patients enrolled, those assigned to receive radiation will receive a single dose of radiation and for patients 21-44, those assigned to receive radiation will receive 2 doses of radiation.
- Conditions
- Metastatic Melanoma
- Being tested
- Radiation therapy and high-dose IL-2, High-dose IL-2
- Keywords
- metastatic melanoma, IL-2, Interleukin 2, Radiation, Stereotactic Body Radiation Treatment, SBRT, Immunotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapy and high-dose IL-2Other
Also called Interleukin 2, Stereotactic Body Radiation Therapy (SBRT)
Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study.
High-dose IL-2Drug
Also called Interleukin 2, Stereotactic Body Radiation Therapy (SBRT).
IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: IL-2 Monotherapy | Active comparator | Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A. Receives: Drug: High-dose IL-2 |
| Arm B: SBRT + IL-2 | Experimental | Patients will receive two doses of radiation before receiving high-dose IL-2. Receives: Other: Radiation therapy and high-dose IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2
Determine the best overall tumor response rate of high dose IL-2 versus SBRT + high-dose IL-2 using RECIST v1.1 assessed by CT/MRI, criteria applied to all target and non-target lesions with the exclusion of sites treated with SBRT. For patients who have SBRT after progression on IL-2 monotherapy, the response rate will be recorded, but not counted as a response for the primary objective.
Overall response rate (ORR) includes all measurable and non-measurable target lesions except the lesions treated by SBRT, which were assessed separately. Both CT and positron emission tomography imaging were employed to assess response.
Complete Response: disappearance of all target/non-target lesions and no abnormalities on PET; Partial Response: ≥30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease: ≥20% increase in sum of LD recorded since tx start or appearance of ≥1 new lesions; Stable Disease: Neither qualifying for PR nor PD since tx started.
Measured: At the end of Cycle 2 (Week 14).
Secondary outcomes (1)
Response Rate in Crossover Patients
Measure the response rate of patients who have disease progression after the first IL-2 cycles (using RECIST criteria) who received SBRT prior to cycle 3 of IL-2.
Measured: 7 weeks following Cycle 2 (Week 21).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study start1 Jul 2011
- Primary completion5 Apr 2017
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Prometheus Laboratories
- Responsible party
- Sponsor
- Investigators
- Brendan Curti, M.D., Principal investigator, Providence Health & ServicesSteven K. Seung, M.D., Principal investigator, Providence Health & ServicesMarka Crittenden, MD, PhD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416831
- Sponsor's protocol ID
- 11-062A
- Acronym
- SBRT/IL-2
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2011
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Curti B, Crittenden M, Seung SK, Fountain CB, Payne R, Chang S, Fleser J, Phillips K, Malkasian I, Dobrunick LB, Urba WJ. Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma. J Immunother Cancer. 2020 May;8(1):e000773. doi: 10.1136/jitc-2020-000773.
PubMed 32467299Sckisel GD, Mirsoian A, Minnar CM, Crittenden M, Curti B, Chen JQ, Blazar BR, Borowsky AD, Monjazeb AM, Murphy WJ. Differential phenotypes of memory CD4 and CD8 T cells in the spleen and peripheral tissues following immunostimulatory therapy. J Immunother Cancer. 2017 Apr 18;5:33. doi: 10.1186/s40425-017-0235-4. eCollection 2017.
PubMed 28428882
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01416831
- Acronym / sponsor ID
- SBRT/IL-2 / 11-062A
- Conditions
- Metastatic Melanoma
- Keywords
- metastatic melanoma, IL-2, Interleukin 2, Radiation, Stereotactic Body Radiation Treatment, SBRT, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Prometheus Laboratories
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Posted 15 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation therapy.
Detailed description
All patients will receive high-dose IL-2. Half the patients enrolled will be randomly selected to receive radiation therapy to up to three tumors prior to receiving high-dose IL-2. Among the first 20 patients enrolled, those assigned to receive radiation will receive a single dose of radiation and for patients 21-44, those assigned to receive radiation will receive 2 doses of radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: IL-2 Monotherapy | Active comparator | Drug: High-dose IL-2Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A. |
| Arm B: SBRT + IL-2 | Experimental | Other: Radiation therapy and high-dose IL-2Patients will receive two doses of radiation before receiving high-dose IL-2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological confirmation of melanoma will be required by previous biopsy or cytology.
- Patients must be ≥ 18 years of age.
- Patients must have tumors amenable to SBRT in lungs, mediastinum, chest wall, bones (other than long bones), or liver (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. Patients may have other metastases but only a maximum of 3 will be treated.
- ECOG performance status of 0-1.
- Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
Key exclusion criteria (13 listed)
- No metastatic site amenable to SBRT.
- Patients with brain metastases not candidates for radiosurgery.
- Previous radiation to sites proposed for radiation as part of this study.
- Patients with active systemic, pulmonary, or pericardial infection.
- Pregnant or lactating women.
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 |
|---|---|---|
| Radiation therapy and high-dose IL-2Also: Interleukin 2, Stereotactic Body Radiation Therapy (SBRT)Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study. | Other | Arm B: SBRT + IL-2 |
| High-dose IL-2Also: Interleukin 2, Stereotactic Body Radiation Therapy (SBRT).IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve. | Drug | Arm A: IL-2 Monotherapy |
Primary outcome
Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2
Time frame: At the end of Cycle 2 (Week 14).
Determine the best overall tumor response rate of high dose IL-2 versus SBRT + high-dose IL-2 using RECIST v1.1 assessed by CT/MRI, criteria applied to all target and non-target lesions with the exclusion of sites treated with SBRT. For patients who have SBRT after progression on IL-2 monotherapy, the response rate will be recorded, but not counted as a response for the primary objective. Overall response rate (ORR) includes all measurable and non-measurable target lesions except the lesions treated by SBRT, which were assessed separately. Both CT and positron emission tomography imaging were employed to assess response. Complete Response: disappearance of all target/non-target lesions and no abnormalities on PET; Partial Response: ≥30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease: ≥20% increase in sum of LD recorded since tx start or appearance of ≥1 new lesions; Stable Disease: Neither qualifying for PR nor PD since tx started.
1 secondary outcome
Response Rate in Crossover Patients
Time frame: 7 weeks following Cycle 2 (Week 21).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32467299Curti B, Crittenden M, Seung SK, Fountain CB, Payne R, Chang S, Fleser J, Phillips K, Malkasian I, Dobrunick LB, Urba WJ. Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma. J Immunother Cancer. 2020 May;8(1):e000773. doi: 10.1136/jitc-2020-000773.
- Derived from this study: PubMed 28428882Sckisel GD, Mirsoian A, Minnar CM, Crittenden M, Curti B, Chen JQ, Blazar BR, Borowsky AD, Monjazeb AM, Murphy WJ. Differential phenotypes of memory CD4 and CD8 T cells in the spleen and peripheral tissues following immunostimulatory therapy. J Immunother Cancer. 2017 Apr 18;5:33. doi: 10.1186/s40425-017-0235-4. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Brendan Curti, M.D. principal investigator
Providence Health & Services
Steven K. Seung, M.D. principal investigator
Providence Health & Services
Marka Crittenden, MD, PhD principal investigator
Providence Health & Services
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 Radiation therapy and high-dose IL-2 and High-dose IL-2 in people with Metastatic Melanoma, run by Providence Health & Services at 1 site in United States.
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 6 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2 (time frame: At the end of Cycle 2 (Week 14).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01416831, which also lists 2 linked publications.
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 24 Apr 2026.