Actively Recruiting
Intrathecal Chemotherapy for Central Nervous System Metastasis in Retinoblastoma
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-02-25
18
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
Sponsors
E
Eye & ENT Hospital of Fudan University
Lead Sponsor
Z
Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Retinoblastoma is the most common intraocular malignancy in infancy and childhood. The overall survival rate of retinoblastoma was reported to exceed 95% when children were early diagnosed with localized intraocular phase. The advanced retinoblastoma cases with central nervous system metastasis (CNS)is associated with exceedingly poor prognosis. CNS metastasis is the main cause of death in retinoblastoma. Meningeal involvement combined with spinal cord membrane involvement might be due to the meninges invasion and/or the spreading of CSF. As the most sensitive drug to retinoblastoma tumor cells in vitro, melphalan is the most important drug in the local treatment of retinoblastoma, and it is also an irreplaceable drug in the current eye preservation treatment, which greatly improves the success rate of eye preservation for advanced retinoblastoma. According to the research and the practice of vitreous injection (melphalan), the drug concentration in vitreous can effectively kill retinoblastoma tumor cells. It is reasonable to speculate that the tumor cells in CSF can be effectively killed by melphalan. Therefore, based on the above background, this study will explore the effectiveness and feasibility of intrathecal injection of melphalan in patients with CNS metastasis of retinoblastoma through a multicenter prospective study.
CONDITIONS
Official Title
Intrathecal Chemotherapy for Central Nervous System Metastasis in Retinoblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of retinoblastoma at stage IVB according to the International Retinoblastoma Staging System
- Presence of tumor cells in cerebrospinal fluid cytology or radiographic evidence of neoplastic meningitis on MRI with histologic diagnosis of systemic malignancy
- Karnofsky Performance Status (KPS) score of 60% or higher
- Adequate bone marrow and organ function
- Informed consent signed by parents and willingness to accept treatment and follow-up
You will not qualify if you...
- Eye diseases other than retinoblastoma
- Eye infection within 30 days before screening
- History of surgery or unhealed wound within 1 month before enrollment
- Allergic reaction or allergy history to chemotherapeutic drugs
- Infectious diseases requiring oral, intramuscular, or intravenous treatment
- Presence of systemic immune diseases
- Active disseminated intravascular coagulation
- Abnormal coagulation function
- Abnormal bone marrow and organ function
- Uncontrollable clinical problems
- Any other conditions deemed exclusionary by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan Eye & ENT Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jiang Qian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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