Loading clinical trials...

Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT01416831•Providence Health & Services

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (1)

Providence Cancer Center

Portland, Oregon, United States

Key Dates

Start Date

July 1, 2011

Primary Completion Date

April 5, 2017

Completion Date

December 1, 2025

Last Updated

March 17, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Melanoma

Interventions

Radiation therapy and high-dose IL-2

OTHER

High-dose IL-2

DRUG

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

RECRUITINGNA

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma

NCT07112170

Metastatic MelanomaOligoProgressive Metastatic Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma.

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3