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



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/20/2018
Start Date:July 2011
End Date:October 2018

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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.

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.

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.
We found this trial at
1
site
Portland, Oregon 97213
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from
Portland, OR
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