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Intra-arterial Chemotherapy for Children With Retinoblastoma

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ClinicalTrials.gov Identifier: NCT00906113
Recruitment Status : Recruiting
First Posted : May 21, 2009
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Weintraub, Hadassah Medical Organization

May 19, 2009
May 21, 2009
October 4, 2016
June 2011
December 2017   (Final data collection date for primary outcome measure)
Salvage of eye and vision [ Time Frame: Three years from intervention ]
Same as current
Complete list of historical versions of study NCT00906113 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intra-arterial Chemotherapy for Children With Retinoblastoma
Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma

Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye.

This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Retinoblastoma
  • Drug: Intra-arterial injection of melphalan
    Injection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses
  • Drug: Injection of melphalan into the ophthalmic artery
    Injection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma
Experimental: Intra-arterial melphalan
The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma
Interventions:
  • Drug: Intra-arterial injection of melphalan
  • Drug: Injection of melphalan into the ophthalmic artery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Same as current
December 2017
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children with retinoblastoma in a single remaining eye with useful vision

Exclusion Criteria:

Sexes Eligible for Study: All
6 Months to 10 Years   (Child)
No
Contact: Michael Weintraub, MD 972-2-6777408 michaelw@hadassah.org.il
Contact: Jacob Pe'er, MD 972-26778431
Israel
 
 
NCT00906113
0058-09-HMO
No
Not Provided
Plan to Share IPD: Yes
Michael Weintraub, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP