Phase I clinical study combining L19-IL2 with stereotactic ablative body radiotherapy in patients with oligometastatic solid tumor

Completed

Conditions: Solid tumors
10029107
Solide tumoren
oligometastatic
10038666

Registration Number: NL-OMON44415

Lead Sponsor: MAASTRO clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

-Histological or cytological confirmed oligometastatic originating from non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), renal cell carcinima (RCC) and melanoma occurring synchronous (at time of diagnosis) or metachronous (> 6 months after radical treatment for primary tumor; i.e., surgically). A biopsy could be omitted in selected cases if a biopsy is medically contraindicated or unfeasible (e.g. fear of entmetastasis, lesion not accessible). In this case the diagnosis of metastatic disease should be certified using an alternative approach (e.g. imaging,...);
-More diffuse metastasized NSCLC patients, with up to 10 metastasis that received standar of care primary chemotherapy with a platinum doublet for a maximum of 6 cycles are also allowed in case these patients showed at least disease control under this treatment (complete remission, partial respnse or stable disease according to RECIST1.1);
-All oligometastatic tumor sites (including brain) are eligible;
-* 5 metastases, or 4 if the primary tumor is to be treated concomitantly;
-* 3 metastatic lesions confined to one organ;
-* 2 organ systems affected with metastases;
-WHO performance status 0-2;
-Adequate bone marrow: Normal white blood cell count and formula, normal platelet count, no anemia requiring blood transfusion or erythropoietin;
-Adequate hepatic function: total bilirubin * 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase * 2.5 x ULN for the institution);
-Adequate renal function: MDRD calculated creatinine clearance at least 60 ml/min;
-The patient is capable of complying with study procedures;
-Signed and dated written informed consent;
-Life expectancy of at least 12 weeks;
-For women of childbearing potential, a negative pregnancy test prior to the first dose of study treatment;
-Men and women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 12 weeks after the last dose of study medication.

Exclusion Criteria

-Other oligometastatic (hormone-sensitive) solid tumors;
-Previous radiotherapy to an area that would be re-treated by SABR;
-Previous systemic treatment to treat recurrent disease;
-Other active malignancy or malignancy within the last 2 years (with exception of localized skin basal/squamous cell carcinoma, bladder in situ carcinoma);
-History of allergy to intravenously administered proteins/peptides/antibodies;
-HIV infection, active infection, or active hepatitis;
-Chronic use of corticosteroids used in the management of cancer or non-cancer-related illness;
-Acute or sub-acute coronary syndromes within the last year, acute inflammatory heart disease, heart insufficiency or irreversible cardiac arrhythmias;
- Impaired cardiac function defined as left ventricular ejection fraction (LVEF) <50% (or below the studý site's lower limit of normal) as measured by MUGA of echo. (LVEF measurements dating back up to 8 weeks will be acceptable in the absence of incurrent use of potentially cardiotoxic treatment or cardiac medical history);
- Uncontrolled hypertensive disease;
-History or evidence of active autoimmune disease;
-Severe diabetic retinopathy;
-Major trauma including surgery within 4 weeks prior to the first L19-IL2 infusion. Focal biopsies in the tumor are allowed;
-Any underlying medical or psychiatric condition which in the opinion of the investigator will make administration of study drug hazardous or hinder the interpretation of study results (e.g., AE);
-Unstable or serious concurrent uncontrolled medical conditions;
-Pregnancy or breast-feeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and Tolerability of the combination treatment (CTCAE4.03).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Progression-free survival, overall survival, local control rate, quality of<br /><br>life (EORTC QLQ-C30 version 3.0 and QLQ-LC13 questionnaires).</p><br>