NCT01899066

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

July 3, 2013

Last Update Submit

May 10, 2014

Conditions

Retinoblastoma

Keywords

Efficacy

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

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

    two years

Secondary Outcomes (1)

  • Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma

    two years

Study Arms (2)

Lucentis; chemotherapy

EXPERIMENTAL

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

chemotherapy

ACTIVE COMPARATOR

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

Drug: chemotherapy

Interventions

Lucentis, chemotherapyDRUG

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.

Also known as: Ranibizumab
Lucentis; chemotherapy
chemotherapyDRUG

chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.

Also known as: vincristine;, carboplatin;, etoposide.
chemotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, +8620, China

RECRUITING

MeSH Terms

Conditions

Retinoblastoma

Interventions

RanibizumabDrug TherapyVincristineCarboplatinEtoposide

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTherapeuticsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCoordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Huasheng Yang

    Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Huasheng Yang, M.D, PHD

CONTACT

+8620-87331539yanghs64@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Efficacy Study of Lucentis in the Treatment of Retinoblastoma

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 15, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

CN(1)