L19-IL2 with stereotactic ablative body radiotherapy


Protocolnummer:
NCT02086721

Ziekenhuizen:
L19-IL2 with stereotactic ablative body radiotherapy

Titel:
| Phase I clinical study combining L19-IL2 with stereotactic ablative body radiotherapy in patients with oligometastatic solid tumor Doel van het onderzoek: To determine the safety and efficacy of L19-IL2 combined with SABR in patients with an oligometastatic solid tumor (non-small cell lung cancer; NSCLC, head and neck squamous cell carcinoma; HNSCC, colorectal cancer; CRC, renal cell carcinoma; RCC, melanoma)

Behandeling:
Oligometastatic solid tumor, Standard of Care Primary Tumor Site, Stereotactic RT 1-5 metastases. L19-IL2: 1 cycle= 3 weeks; max. 6 cycles. Day 1: Admission VEA5 or day clinic internal medicine: L19-IL2 dose; Day 3: Admission VEA5 or day clinic internal medicine: L19-IL2 dose; Day 5: Admission VEA5 or day clinic internal medicine: L19-IL2 dose; Day 7: Visit outpatient clinic for assesments; Day 14: Visit outpatient clinic for assesments; Day 21: Visit outpatient clinic for assesments= start cycle2

Stadium:

Belangrijkste in/exclusiecriteria:
| Inclusion criteria for all patients 1. Histological or cytological confirmed oligometastatic originating from NSCLC, HNSCC, CRC, 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 ent-metastasis, lesion not accessible). In this case the diagnosis of metastatic disease should be certified using an alternative approach (e.g. imaging, ….. ) 2. determination of possible activating mutations (e.g., ALK/EGFR/ROS in NSCLC, and BRAF, NRAS and KIT in melanoma) 3. All oligometastatic tumor sites (including brain) are eligible; 4. ≤ 5 metastases, or 4 if the primary tumor is to be treated concomitantly; 5. ≤ 3 metastatic lesions confined to one organ; 6. ≤ 2 organ systems affected with metastases; 7. Life expectancy of at least 12 weeks; Exclusion criteria 1. Other oligometastatic (hormone-sensitive) solid tumors; 2. Previous radiotherapy to an area that would be re-treated by SABR; 3. Previous systemic treatment to treat recurrent disease; 4. Other active malignancy or malignancy within the last 2 years (with exception of localized skin basal/squamous cell carcinoma, bladder in situ carcinoma); 5. HIV infection, active infection, or active hepatitis; 6. Chronic use of corticosteroids used in the management of cancer or non-cancer-related illness; 7. Acute or sub-acute coronary syndromes within the last year, acute inflammatory heart disease, heart insufficiency or irreversible cardiac arrhythmias; 8. Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % (or below the study site’s lower limit of normal) as measured by MUGA or ECHO. (LVEF measurements dating back up to 8 weeks will be acceptable in the absence of intercurrent use of potentially cardiotoxic treatment or cardiac medical history); 9. Uncontrolled hypertensive disease; 10. History or evidence of active autoimmune disease; 11. Severe diabetic retinopathy;

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