A Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma (EuRbG2018)
Eye Cancer, Retinoblastoma
About this trial
This is an interventional treatment trial for Eye Cancer, Retinoblastoma focused on measuring relapsed retinoblastoma, relapse of retinoblastoma
Eligibility Criteria
Inclusion Criteria:
Eye with recurrent Rb clinically defined as one or the combination of the following:
- vitreous recurrence only
- retinal / diffuse subretinal relapse only not amenable to focal treatment such as thermotherapy, cryotherapy or plaque
- combined vitreous and retinal/diffuse subretinal relapse
- Minimally required interval between study entry and time of the last treatment: 2 months (with a monthly follow-up), except for small retinal / subretinal tumors treated focally, not related to the current relapse
- Photographic documentation of fundus at study entry
- Registration into the study and start of treatment must occur no later than 14 days after diagnosis of recurrence
- Mandatory ultrasound biomicroscopy (UBM) at 35 or 50 MHz in case of opaque media or insufficient pupillary dilatation for evaluation of the posterior chamber / pars plana
- Age ≥3 months and < 11 years (10.99)
- Weight ≥5 kg (in case of IAC eligibility or sequential IVitC/IAC eligibility)
- Possibility of follow-up until at least 2 years after end of current relapse treatment
- Written informed consent by parents or legal representative before enrolment
Exclusion Criteria:
- Relapse with any uveal involvement and/or anterior chamber involvement
- Indication for another treatment option according to investigator's judgement
- Clinical/MRI signs of extraocular disease, including metastatic disease
Inadequate organ function (in case of IAC or sequential IVitC / IAC eligibility):
- absolute neutrophils count <0.5 G/l
- thrombocytes count <100 G/l
- creatinine above normal value for age
- ALAT more than 2x above upper normal limit
- bilirubin above upper normal limit
- Other (simultaneous) malignancies
- Contraindication or known hypersensitivity to study drugs
- Severe concomitant diseases (e.g. immune deficiency syndrome)
- Current or recent (within 30 days prior to date of written informed consent) treatment with another investigational drug or participation in another interventional clinical trial
Sites / Locations
- CHUV Lausanne University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Active Comparator
Experimental
Active Comparator
Experimental
No Intervention
No Intervention
No Intervention
Treatment 1a
Treatment 1b
Treatment 2a
Treatment 2b
Treatment 2c
Treatment 3a
Treatment 3b
IVitC melphalan (randomized) in case of vitreous relapse only
IVitC topotecan (randomized) in case of vitreous relapse only
IAC melphalan (randomized) in case of retinal/diffuse subretinal relapse with no prior intra-arterial treatment
IAC melphalan and topotecan (randomized) in case of retinal/diffuse subretinal relapse with no prior intra-arterial treatment
IAC melphalan and topotecan (randomized) in case of retinal/diffuse subretinal relapse with prior intra-arterial treatment
sequential administration of IVitC melphalan and IAC melphalan in case of combined vitreous and retinal/diffuse subretinal relapse, if no pretreatment with intra-arterial treatment
sequential administration of IVitC melphalan and IAC melphalan and topotecan, in case of combined vitreous and retinal/diffuse subretinal relapse, if prior pretreatment with intra-arterial treatment