Efficacy Study of Lucentis in the Treatment of Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Lucentis in the Treatment of Retinoblastoma - A Phase II, Single Center, Randomized Study to Evaluate the Efficacy of Ranibizumab in Subjects With Retinoblastoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01899066
• Other study ID #: yanghs20130627
• Status: Recruiting
• Phase: Phase 2
• First received: July 3, 2013
• Last updated: May 10, 2014
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: Sun Yat-sen University
• Contact: Huasheng Yang, M.D, PHD
• Phone: +8620-87331539
• Email: yanghs64[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• Lucentis, chemotherapy
Lucentis:0.50mg/0.05ml, intravitreal injection,monthly for the first six months. chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.
• chemotherapy
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality	measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years	two years	No
Secondary	Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma	measure the tumor size and new vessels by ultrasonography,fundus photography and fundoscopy before each treatment, and 1,3,6,9,12,18,24 months after the treatment.	two years	No