Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma (NCT02097134) | Clinical Trial Compass
CompletedPhase 1
Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma
United States14 participantsStarted 2014-10-31
Plain-language summary
This pilot clinical trial studies whether unilateral group D retinoblastoma, or retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can be treated with a new technique for delivering chemotherapy directly into the blood vessel that supplies the affected eye. This new technique is called intra-arterial injection. Giving melphalan via intra-arterial injection may make it less likely that children will need surgery to remove the eye and may reduce the amount of treatment side effects.
Who can participate
Age range6 Months
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:
* Newly diagnosed patients with unilateral group D retinoblastoma
* Magnetic resonance imaging (MRI) (or computed tomography \[CT\] if MRI is not available) of the brain must be performed within 14 days prior to study entry
* Diagnostic examination under anesthesia (EUA) must be performed within 14 days prior to study entry
* Rapid central review confirmation of group D disease based on RetCam images from diagnostic EUA must be obtained before starting treatment
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2
* Patients must have a life expectancy of \>= 8 weeks
* Patients must have adequate renal function, defined as:
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or
* A serum creatinine based on age/gender as follows:
* 1 month to \< 6 months: 0.4 mg/dL
* 6 months to \< 1 year: 0.5 mg/dL
* 1 to \< 2 years: 0.6 mg/dL
* 2 to \< 6 years: 0.8 mg/dL
* 6 to \< 10 years: 1 mg/dL
* 10 to \< 13 years: 1.2 mg/dL
* 13 to \< 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
* \>= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 x upper limit of normal (ULN) for age
Exclusion Criteria:
* Patients with bilateral disease
* Unilateral retinoblastoma with group A, B…
What they're measuring
1
Number of Patients Experiencing Feasibility Failure