NCT01151748

Brief Summary

Phase II study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 4, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

March 4, 2010

Last Update Submit

May 10, 2012

Conditions

RetinoblastomaEye Cancer

Outcome Measures

Primary Outcomes (1)

  • Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination.

    Follow-up will be performed for one year from treatment date.

Interventions

Intra-arterial infusion of chemotherapyPROCEDURE

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients diagnosed with advanced intraocular retinoblastoma (International Retinoblastoma Classification group D or E\*).
  • Patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy.

You may not qualify if:

  • Congenital brain anomaly identified on MRI.
  • History of systemic coagulopathy.
  • Evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

RetinoblastomaEye Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jonathan W Kim

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2010

First Posted

June 28, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

US(1)