NCT01416831Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 12 Aug 2011
- Start date
- 1 Jul 2011
- Primary completion date
- 5 Apr 2017
- Lead sponsor
- Providence Health & Services
- Diseases
- Melanoma
- NCT number
- NCT01416831
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 44
- From 1 Jul 2011 to the primary completion date, 5 Apr 2017
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiation to sites proposed for radiation as part of this study.
- Patient requires chronic steroids.
Other illness
- Patients with active systemic, pulmonary, or pericardial infection.
- 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.
Lab values
- 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
Other
- No metastatic site amenable to SBRT.
- Patients with brain metastases not candidates for radiosurgery.
- Pregnant or lactating women.
- Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Providence Cancer Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.