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Radiation plus immunotherapy: a new hope for melanoma?

NCT ID NCT01416831

Disease control Sponsor: Providence Health & Services Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two treatments for metastatic melanoma that has spread: high-dose Interleukin-2 (IL-2) alone versus IL-2 combined with targeted radiation (SBRT). The goal is to see if adding radiation helps shrink tumors better than IL-2 alone. The trial enrolled 44 adults with tumors that could be safely radiated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

44 people

The number who actually took part.

Started

Jul 2011

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic melanoma

Contacts and locations

Locations

  • Providence Cancer Center

    Portland, Oregon, 97213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.