Clinical trial NCT01416831: Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma.
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metastatic Melanoma
Keywords: metastatic melanoma
IL-2
Interleukin 2
Radiation
Stereotactic Body Radiation Treatment
SBRT
Immunotherapy
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: Prometheus Laboratories
First posted: 2011-08-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2
timeFrame: At the end of Cycle 2 (Week 14).
Secondary outcomes:
measure: Response Rate in Crossover Patients
timeFrame: 7 weeks following Cycle 2 (Week 21).
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence Cancer Center
state: Oregon
Study officials:
affiliation: Providence Health & Services
name: Brendan Curti, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Health & Services
name: Steven K. Seung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Health & Services
name: Marka Crittenden, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curti 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.
citation: Sckisel 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.