NCT04903678Recruiting
Intrathecal Chemotherapy for Central Nervous System Metastasis in Retinoblastoma
Intrathecal Chemotherapy for Central Nervous System Metastasis in Retinoblastoma (A Multicenter Prospective Single Arm Trial)
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 22 May 2021
- Start date
- 1 May 2021
- Primary completion date
- 1 May 2028
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Diseases
- Childhood cancers
- NCT number
- NCT04903678
What you commit to
- Study type: Interventional
- Planned participants: 18
- From 1 May 2021 to the primary completion date, 1 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The eyes were infected within 30 days before screening
- There was a history of surgery and / or unhealed wound within 1 month before enrollment .
Other illness
- 1.Eye diseases other than retinoblastoma
- Those who have allergic reaction or allergic history to chemotherapeutic drugs.
- Infectious diseases requiring oral, intramuscular or intravenous administration.
- Patients with systemic immune diseases.
Other
- Active disseminated intravascular coagulation.
- Abnormal coagulation function.
- Abnormal bone marrow and organ function.
- Uncontrollable clinical problems.
- The researchers believe that those who need to be excluded.
Who the study is looking for
- The pathological diagnosis was retinoblastoma. According to the IRSs (International retinoblastoma staging system) staging system, the stage was IVB
- CSF tumor cells on cytology, or radiographic evidence of NM on MRI scans and histologic diagnosis of systemic malignancy needed
- KPS≥60%
- Adequate bone marrow and organ function
- The parents signed the informed consent and were willing to accept the treatment and follow-up.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan Eye & ENT Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.