Efficacy Study of Lucentis in the Treatment of Retinoblastoma

May 10, 2014 updated by: Huasheng Yang, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, +8620
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

Other Names:
  • Ranibizumab
Active Comparator: chemotherapy
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Drug: chemotherapy
chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.
Other Names:
  • vincristine;
  • carboplatin;
  • etoposide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma
Time Frame: two years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Huasheng Yang, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 10, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yanghs20130627

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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