Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced … (NCT01393769) | Clinical Trial Compass
TerminatedPhase 2
Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular Stage
Stopped: Only 5 subjects could be enrolled. Sample of 25 pat. not be achieved (rare disease).
Spain5 participantsStarted 2009-11
Plain-language summary
For selected cases with advanced Retinoblastoma (RTB) intraocular involvement(stage V of the Reese-Ellsworth classification) in which enucleation would usually be the standard therapeutic approach, in this project the investigators propose an alternative conservative treatment using intra-arterial chemotherapy with melphalan, via direct administration by catheterization of the ophthalmic artery.
Who can participate
Age range6 Months – 6 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with unilateral RTB.
✓. Patients with advanced intraocular involvement, corresponding to Stage D of the International Classification , selected by the Tumour Committee of the Retinoblastoma Unit.
Exclusion criteria
✕. The only alternative to treatment is enucleation.
✕. Over six months old at diagnosis and younger than six years old.
✕. Informed consent of the parents or legal representative.
✕. Under 6 months old at diagnosis.
✕. Impaired kidney function, with creatinine clearance lower than 80 mL/min/1.73m2 or serum creatinine higher than 0.7 mg/dL.
✕. Impaired liver function, normal function being defined as presenting total bilirubin levels lower than 1.5 times the limit of normal for that age and ALT lower than 5 times the limit of normal for that age.
✕. Patients with some type of coagulation disorder that could contraindicate the procedure or with a previous diagnosis of any thrombotic condition.
What they're measuring
1
To assess the saving of eyes affected with RTB for patients who would have been candidates for enucleation.
Timeframe: From V1 (Baseline) to V14 (1+ year after last treatment)
2
The response will be evaluated as a function of tumoral volumetric size.
Timeframe: From V1 (Baseline) to V14 (+1 year after last treatment)
✕. Congenital cerebral anomalies diagnosed previously or detected by angioresonance prior to treatment for extraocular involvement by RTB shown by image techniques, cerebrospinal fluid (CSF) cytology or cytomorphology of bone marrow aspirates (BMA), or positive expression of GD2 synthase in CSF or BMA.