Clinical trial · Interventional
Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma.
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
NCT01416831CI-TRIAL-00109383SBRT/IL-2active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-dose IL-2 | Drug | — | UNRESOLVED |
| Radiation therapy and high-dose IL-2 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: IL-2 Monotherapy
- description
- 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.
- interventionNames
- Drug: High-dose IL-2
- type
- EXPERIMENTAL
- label
- Arm B: SBRT + IL-2
- description
- Patients will receive two doses of radiation before receiving high-dose IL-2.
- interventionNames
- Other: Radiation therapy and high-dose IL-2
Primary outcomes (1)
- measure
- Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
References
Publications (2)
- DERIVEDCurti 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. PMID 32467299
- DERIVEDSckisel 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. PMID 28428882