pediatric patients with HGG/DIPG MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 64RAME CLORURO
Product Code: [64Cu(II)Cl2]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: rame cloruro ( 64CuCl2)
Current Sponsor code: (64Cu)CuCl2
Concentration unit:
Sponsors
ENTE OSPEDALIERO OSPEDALI GALLIERA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or radiologically confirmed High grade Glioma or diffuse intrinsic pontine glioma (DIPG) 2. Measurable disease (at least one objectively bi-dimensionally measurable lesion (> 1 cm in its largest dimension by RM scan) as demonstrated by RM scan. 3.KPS = 60. 4. A life expectancy > 3 months. 5. Male or female aged ranging from 5 to 18 years. 6. Normal marrow function defined as: a. Absolute neutrophil count = 1.5 x 109/l b. Platelet count = 150 x 109/l c. Haemoglobin = 9 g/dl. 7. Adequate hepatic function, defined as: a. AST/ALT = 2.5 x upper limit of normal (ULN) (or = 5.0 x ULN if liver involvement by primary disease) direct bilirubin = 1.5 ULN b. Normal ALP values c. Normal coagulation parameters. 8. Adequate renal function as demonstrated by a serum creatinine = 1.5 mg/dl or a creatinine clearance > 60 ml/min. 9. Negative human chorionic gonadotropin (hCG) test in women of childbearing potential. Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 4 months after final administration of 64CuCl2, or the patient must be sterile (with documentation in the patient’s medical records). Note: Sterility (in female patients) must be confirmed in the patients’ medical records and can be defined as any of the following: surgical hysterectomy with bilateral oophorectomy; radiation-induced oophorectomy with last menses >1 year ago; chemotherapy-induced menopause with 1 year interval since last menses. 10. Written, informed consent prior to the present study and to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient or by the parents/legal tutors at any time without prejudice. 11. Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document. 15.TBR > 5 Are the trial subjects under 18? yes 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 2 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Histology other than High Grade Glioma. 2. Contraindication to MRI with gadolinium. 3. Copper metabolic disorders (i.e. known Wilson disease or Menkes disease). 4. Patients who have not recovered from adverse events Grade > 1 due to diagnostic injection of Cuprymina. 5. Pregnant or breastfeeding women. 6.Sexually active male and female patients of childbearing potential without use of an effective method of birth control. 7.Known HIV disease or acquired immunodeficiency syndrome-related illness or active hepatitis B or C infection. 8. Uncontrolled Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the diagnostic accuracy of 64CuCl2-PET / CT in identifying HGG and DIPG Correlate the intensity of 64CuCl2 with tumor aggressiveness Evaluate the prognostic impact of 64CuCl2 (i.e. the ability to identify patients at increased risk of disease progression);Secondary Objective: To study biodistribution, kinetics and dosimetry based on MIRD method of 64CuCl2 both in the tumor lesion and in the organs Evaluating the Tumor to Background ratio (TBR) of 64CuCl2 in function of time Evaluate the safety and tolerance of 64CuCl2 and possible occurrence of adverse events;Primary end point(s): Evaluate the diagnostic accuracy of 64CuCl2-PET / CT in identifying HGG and DIPG Correlate the intensity of 64CuCl2 with tumor aggressiveness Evaluate the prognostic impact of 64CuCl2 (i.e. the ability to identify patients at increased risk of disease progression);Timepoint(s) of evaluation of this end point: 16 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To study biodistribution, kinetics and dosimetry based on MIRD method of 64CuCl2 both in the tumor lesion and in the organs Evaluating the Tumor to Background ratio (TBR) of 64CuCl2 in function of time Evaluate the safety and tolerance of 64CuCl2 and possible occurrence of adverse events;Timepoint(s) of evaluation of this end point: 16 months | — |
Countries
Italy
Contacts
Public ContactS.C. Medicina Nucleare
E.O. Ospedali Galliera
Outcome results
None listed