Eye Cancer, Retinoblastoma Clinical Trial
— EuRbG2018Official title:
A Phase II Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma, With Randomization Depending on the Site of Relapse or on Previous Treatment
Verified date | September 2023 |
Source | University of Lausanne Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 modalities have been developed to give the chance of cure also in relapse, avoiding enucleation which results in esthetic sequelae and orbital growth problems, and radiotherapy which significantly increases the risk of secondary cancers in hereditary retinoblastoma. The current protocol aims at covering all types of relapses in retinoblastoma, with treatments adapted to the site of relapse, at harmonizing the new eye- and vision-preserving treatment procedures, and evaluating their efficacy and toxicity.
Status | Terminated |
Enrollment | 2 |
Est. completion date | May 22, 2023 |
Est. primary completion date | May 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 11 Years |
Eligibility | Inclusion Criteria: 1. 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 2. 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 3. Photographic documentation of fundus at study entry 4. Registration into the study and start of treatment must occur no later than 14 days after diagnosis of recurrence 5. 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 6. Age =3 months and < 11 years (10.99) 7. Weight =5 kg (in case of IAC eligibility or sequential IVitC/IAC eligibility) 8. Possibility of follow-up until at least 2 years after end of current relapse treatment 9. Written informed consent by parents or legal representative before enrolment Exclusion Criteria: 1. Relapse with any uveal involvement and/or anterior chamber involvement 2. Indication for another treatment option according to investigator's judgement 3. Clinical/MRI signs of extraocular disease, including metastatic disease 4. 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 5. Other (simultaneous) malignancies 6. Contraindication or known hypersensitivity to study drugs 7. Severe concomitant diseases (e.g. immune deficiency syndrome) 8. 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | CHUV Lausanne University Hospital | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Prof. Beck Popovic Maja |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of retinal toxicity of intravitreous administration of melphalan versus topotecan assessed by CTCAE v5.0 | parameters: salt and pepper retinopathy, choroidopathy, number of injections until toxicity | at 1 month after treatment completion | |
Primary | Relapse rate after IAC by melphalan only and IAC by melphalan + topotecan | parameter: eye retention rate | at 2 years of follow-up | |
Secondary | Efficacy of intravitreous topotecan compared to intravitreous melphalan (number of injections to tumor clearance in vitreous) | Parameter: number of injections to tumor clearance in vitreous | at 3 or 6 months after last intravitreous injection | |
Secondary | Ocular survival (eye salvage rate) | parameters: enucleation and EBR | at 2 years since study entry | |
Secondary | Number of participants with ocular (non retinal) and systemic toxicity assessed by CTCAE v5.0 | parameter: number of participants | Weekly (IVitC) or monthly (IAC) during treatment, at end of treatment (1 month after last injection), at 6, 12 and 24 months, yearly until 60 months | |
Secondary | Quality of vision assessed by visual acuity | parameters: Logmar values | at 5 years of age | |
Secondary | Incidence of early (within 1 month), intermediate (2-12 months) and late (> 12 months) ocular and systemic general adverse events during regular ophthalmological and clinical examinationassessed by CTCAE v5.0 | parameter: incidence | Weekly (IVitC) or monthly (IAC) during treatment, at end of treatment (1 month after last injection), at 6, 12 and 24 months, yearly until 60 months | |
Secondary | Quantification of the cumulative radiation exposure during the IAC procedures by routinely used devices (sub-study limited to Lausanne) by B three thermoluminescent dosimeters | parameter: B three thermoluminescent dosimeters | at 1 month after the last IAC | |
Secondary | Incidence of the occurrence of secondary malignancies and/or metastases and long term sequelae | parameter: incidence | during a follow-up of at least 10 years |