Study evaluating AGuIX® nanopartcles in combinaison with radiotherapy for progressive / recurrent inoperable musculoskeletal tumor lesion.

Phase 1

Active, not recruiting

• Conditions: Patients with metastatic renal cancer, melanoma or sarcoma, or with non-metastatic sarcoma (soft tissue, chondrosarcoma, osteosarcoma…), and with a progressive / recurrent inoperable musculoskeletal tumor lesion.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000571-37-FR
• Lead Sponsor: Centre Léon Bérard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-03
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

I1. Male or female patients aged of at least 18 years on day of signing informed consent.
I2. Histologically-confirmed diagnosis of:
- Metastatic renal cancer, sarcoma, or melanoma, with the presence of at least one progressive / recurrent inoperable musculoskeletal tumor lesion eligible for radiotherapy
Note: - Only one lesion can be treated with this protocol.
- Long bones should be excluded this is not a good indication for stereotactic radiotherapy.
- or Non-metastatic sarcoma with musculoskeletal tumor lesion eligible for radiotherapy i.e.:
o inoperable
o partially resected with macroscopic (R2) residual tumor
o locally recurrent lesion after surgery (R0 or R1).
I3. For metastatic patients:
o Currently being treated with first- or second-line therapy in the metastatic setting.
o No RECIST v1.1 progression of tumor lesions that will not be treated by RT, documented by radiological assessment within 4 weeks before inclusion.
o Radiological evidence of a maximum of 5 metastases in less than 3 organs.
I4. Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
I5. Life expectancy of at least 12 months.
I6. For vertebral metastatic lesions, Spinal Instability Neoplastic Score (SINS) < 12 and BILSKY grade < 2.
Note: In case of BILSKY grade 2, a surgical opinion must be taken before inclusion. In case of SINS = 12 and BILSKY grade 3, decompression or stabilization surgery must be performed before inclusion (refer to criterion E5).
I7. Documented adequate organ function as defined in the table below according to laboratory tests performed within 7 days prior Day 1:
Absolute neutrophil count (ANC) = 1.0 G/L ; Platelets = 75 G/L ; Hemoglobin = 8 g/dL (without transfusion within 7 days) ; Serum creatinine OR Creatinine clearance according to CKD-EPI = 1.5 x Upper Limit of Normal (ULN) OR = 50 mL/min/1.73m2 ; AST and ALT = 3 x ULN (or = 5.0 ULN in case of liver metastasis or hepatic infiltration) ; INR and Activated Partial Thromboplastin Time (aPTT)=1.5 x ULN
I8. Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of the study drug.
I9. Fertile men must agree to use contraceptive measures up to 3 months after the last dose of study drug.
I10. Patients who understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures. Patient should be able and willing to comply with study visits and procedures as per protocol.
I11. Patients must be covered by a medical insurance.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

E1. Patients participating to another clinical trial with an investigational agent.
E2. Patients who have not recovered from significant adverse events (i.e. grade > 2 AE according to NCI CTCAE v5.0) due to prior treatment with anti-cancer agents with the exception of any grade alopecia or lab values presented in inclusion criteria I8.
E3. Patients with carcinomatous meningitis, peritoneal carcinosis or bone marrow involvement.
E4. Patients with prior local treatment with radiotherapy of the tumor lesion eligible for this protocol.
E5. Patients currently treated with Bevacizumab.
E6. Patients using, or requirement to use while on the study, or not respecting the minimal wash-out period of concomitant medications.
E7. Patients with known arterio-venous malformation near the treatment area.
E8. Patients unable to undergo or tolerate Magnetic Resonance Imaging or with known contra-indication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements or certain metal implants).
E9. Patients with known contra-indication, sensitivity or allergy to gadolinium.
E10. Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate study drug or would likely interfere with study procedures or results.
E11. Patients who are pregnant or breastfeeding women or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified