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Efficacy Study of Lucentis in the Treatment of Retinoblastoma

Primary Purpose

Retinoblastoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lucentis, chemotherapy
chemotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinoblastoma focused on measuring Efficacy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lucentis; chemotherapy

chemotherapy

Arm Description

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.

chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.

Outcomes

Primary Outcome Measures

all cause mortality
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years

Secondary Outcome Measures

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.

Full Information

First Posted
July 3, 2013
Last Updated
May 10, 2014
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01899066
Brief Title
Efficacy Study of Lucentis in the Treatment of Retinoblastoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma
Keywords
Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lucentis; chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Intervention Type
Drug
Intervention Name(s)
Lucentis, chemotherapy
Other Intervention Name(s)
Ranibizumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Other Intervention Name(s)
vincristine;, carboplatin;, etoposide.
Intervention Description
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.
Primary Outcome Measure Information:
Title
all cause mortality
Description
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years
Time Frame
two years
Secondary Outcome Measure Information:
Title
Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma
Description
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.
Time Frame
two years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huasheng Yang, M.D, PHD
Phone
+8620-87331539
Email
yanghs64@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
+8620
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, MD,PHD
Phone
+862087331539
Email
yanghs64@126.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Lucentis in the Treatment of Retinoblastoma

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