Clinical trial · Interventional
A Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties in recruiting patients due to changing in treatment standards for the target population
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Eye Cancer, Retinoblastoma | Malignant Eye Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (7)
- type
- ACTIVE_COMPARATOR
- label
- Treatment 1a
- description
- IVitC melphalan (randomized) in case of vitreous relapse only
- interventionNames
- Drug: Melphalan
- type
- EXPERIMENTAL
- label
- Treatment 1b
- description
- IVitC topotecan (randomized) in case of vitreous relapse only
- interventionNames
- Drug: Topotecan
- type
- ACTIVE_COMPARATOR
- label
- Treatment 2a
- description
- IAC melphalan (randomized) in case of retinal/diffuse subretinal relapse with no prior intra-arterial treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Months
- Maximum age
- 11 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available