Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

This study is currently recruiting participants.
Verified February 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01293539
First received: January 21, 2011
Last updated: February 21, 2014
Last verified: February 2014

January 21, 2011
February 21, 2014
March 2011
August 2015   (final data collection date for primary outcome measure)
Number of patients who complete therapy without the need for additional treatment including systemic chemotherapy, external beam radiation, or enucleation. [ Time Frame: Within the first six months after the initial treatment. ] [ Designated as safety issue: No ]
The primary objective of this study is to show that intra-arterial delivery of the chemotherapeutic agent is successful in treating intraocular retinoblastoma, defined as avoiding systemic chemotherapy, external beam radiation, and enucleation.
Same as current
Complete list of historical versions of study NCT01293539 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

The purpose of this study is to show that chemotherapy delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment alternative to conventional systemic chemotherapy, external beam radiation, and surgical removal of the eye.

Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Administration of the drug directly to the targeted site thus avoids the complications and adverse events associated with toxicity from systemic, rather than local, chemotherapy.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Retinoblastoma
Drug: Melphalan hydrochloride

Drug administered intra-arterially (injection in the artery).

Standard dose:

2.5mg (3-6 month old) 3.0 mg (6-12 month old) 4.0 mg (1-3 year old) 5.0 mg (>3 years old)

Dose modification: decrease standard dose by 25% if there are signs of toxicity. Increase the dose by 25% if there is inadequate tumor response.

Frequency: 2 treatment cycles at 3-4 week intervals, with a third treatment cycle administered if the tumor requires it.

Dose not to exceed 0.5mg/kg, per treatment cycle.

Other Name: Alkeran
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
August 2021
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients newborn to 18 years old.
  • Patients with intraocular retinoblastoma, unilateral or bilateral, who would be treated either by systemic chemotherapy, EBR, or enucleation would be considered for this study.

Exclusion Criteria:

  • Patients over the age of 18.
  • Patients with small, localized intraocular Rb amenable to focal therapy (laser or cryotherapy).
  • Patients with extraocular disease evident on MRI (extension into the optic nerve), massive choroidal/uveal invasion (grade IIC or IID per ARET0332) or disease outside the globe evident on MRI or physical examination.
  • Documented hypercoagulable disorders or vasculopathies.
  • Laboratory exclusion criteria: GFR < 60 mL/min/1.73 m2
Both
up to 18 Years
No
Contact: Monica Pearl, M.D. 410-955-8525 msmit135@jhmi.edu
Contact: Amber Jones, B.A., CCRP 410-502-0736 ajones78@jhmi.edu
United States
 
NCT01293539
J1071, NA_00040637
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Monica Pearl, M.D. The Johns Hopkins Hospital
Sidney Kimmel Comprehensive Cancer Center
February 2014

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