Lucentis in the Treatment of Retinoblastoma - A Phase II, Single Center, Randomized Study to Evaluate the Efficacy of Ranibizumab in Subjects With Retinoblastoma
Overview
- Phase
- Phase 2
- Intervention
- Lucentis, chemotherapy
- Conditions
- Retinoblastoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- all cause mortality
- Last Updated
- 11 years ago
Overview
Brief Summary
This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.
Detailed Description
This study will be a phase II open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without intravitreal ranibizumab at a dose of 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .
Investigators
Huasheng Yang
Efficacy Study of Lucentis in the Treatment of Retinoblastoma
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Definite characteristic signs of retinoblastoma,Group D base on Intraocular International Retinoblastoma classify, IIRC.
Exclusion Criteria
- •History of surgical intervention for retinoblastoma in the study eye.
- •Any previous disease in the study eye.
- •Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
- •Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
Arms & Interventions
Lucentis; chemotherapy
Lucentis: 0.5mg/0.05 ml;Other Name: Ranibizumab;monthly for the first six months. Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Intervention: Lucentis, chemotherapy
chemotherapy
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Intervention: chemotherapy
Outcomes
Primary Outcomes
all cause mortality
Time Frame: two years
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years
Secondary Outcomes
- Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma(two years)