Status:
TERMINATED
A Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma
Lead Sponsor:
Prof. Beck Popovic Maja
Conditions:
Eye Cancer, Retinoblastoma
Eligibility:
All Genders
3-11 years
Phase:
PHASE2
Brief Summary
While 95% of patients with retinoblastoma can be cured nowadays, treatment of relapse remains challenging, ending often in enucleation and/or radiotherapy. In the last 10 years, new treatment modaliti...
Detailed Description
The study aims at improving treatment of patients with recurrent Rb through a specific approach according to the site of relapse and a uniform and well-defined treatment schedule. A precise observatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04455139
Start Date
November 15 2021
End Date
May 22 2023
Last Update
October 3 2023
Active Locations (1)
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1
CHUV Lausanne University Hospital
Lausanne, Switzerland, 1011