Intra-arterial Chemotherapy for Retinoblastoma (NCT04342572) | Clinical Trial Compass
CompletedPhase 1
Intra-arterial Chemotherapy for Retinoblastoma
United States5 participantsStarted 2020-08-11
Plain-language summary
Children with retinoblastoma who may benefit from intra-arterial chemotherapy will receive up to 3 doses of melphalan and will be assessed for feasibility, toxicity, and response.
Who can participate
Age range4 Months
SexALL
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Inclusion Criteria:
* Patients diagnosed with retinoblastoma \>4 months of age16
* Patients whose other treatment options would require systemic chemotherapy, radiotherapy, or enucleation
* Patient or parent/legal guardian must sign a written informed consent
* One of a, b, or c:
* Patients who have bilateral COG stage B, C, D, or E retinoblastoma (refer to Appendix A) who have undergone systemic chemotherapy without resolution (meaning either has not had CR or has progressed despite systemic chemotherapy) and would have the following treatment options remaining:
* IAC
* enucleation of one eye
* local radiation
* Patients with non-germline retinoblastoma with unilateral disease who have COG A, B, C, or D tumors (refer to Appendix A).
* Other patients may be considered on a case by case basis after discussion with pediatric ophthalmology, hematology/oncology, and interventional neuroradiology.
Exclusion Criteria:
* Opaque or hazy media which precluded visualization of the fundus.
* New or recurrent retinoblastoma that can be controlled with other conservative measures such as cryotherapy, thermotherapy, or plaque radiotherapy.
* Unilateral COG group E retinoblastoma (refer to Appendix A) with very poor visual prognosis as defined by pediatric ophthalmologist.
* Patients who would benefit from systemic chemotherapy.
* Patients with clinical or radiological evidence suggestive of retinoblastoma invasion of the optic nerve, choroid, sclera, orbit or metasta…
What they're measuring
1
Feasibility of intra-arterial chemotherapy as measured by the number of participants who receive 3 intra-arterial injections of melphalan
Timeframe: Completion of enrollment and treatment of all patients (estimated to be 32 months)