Intra-arterial Chemotherapy for Advanced Intraocular Reti... | NCT01151748

Studies
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

NCT01151748

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

May 14, 2012Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Retinoblastoma
Eye Cancer

Interventions

Intra-arterial infusion of chemotherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SU-07072009-3000	Other Identifier	Stanford University

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study abandoned; Could not obtain final SRC approval due to IND disagreements

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Mar 2011Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Mar 4, 2010

First Submission Date that Met QC Criteria

Jun 25, 2010

First Posted Date

Jun 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2012

Last Update Posted Date

May 14, 2012Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Intra-arterial infusion of chemotherapy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan W Kim	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D012175	Retinoblastoma
D005134	Eye Neoplasms

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided