Efficacy Study of Lucentis in the Treatment of Retinoblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Huasheng Yang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01899066
First received: July 3, 2013
Last updated: May 10, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Retinoblastoma
Drug: Lucentis, chemotherapy
Drug: chemotherapy
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: two years ] [ Designated as safety issue: No ]
    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 [ Time Frame: two years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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 .

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899066

Contacts
Contact: Huasheng Yang, M.D, PHD +8620-87331539 yanghs64@126.com

Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, +8620
Contact: Huasheng Yang, MD,PHD    +862087331539    yanghs64@126.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Huasheng Yang Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Huasheng Yang, Efficacy Study of Lucentis in the Treatment of Retinoblastoma, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01899066     History of Changes
Other Study ID Numbers: yanghs20130627
Study First Received: July 3, 2013
Last Updated: May 10, 2014
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Efficacy

Additional relevant MeSH terms:
Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases
Etoposide
Vincristine
Etoposide phosphate
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014