Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma (RELRB1)
Recruitment status was Recruiting
The investigators are testing subtenon carboplatin in combination with vincristine and topotecan given by vein in the hopes of finding a drug combination that may be effective against retinoblastoma that has come back (recurrent) or is resistant to other treatment (refractory).
The goals of this study are:
- To decide if the drug combination is a useful treatment for recurrent or refractory retinoblastoma
- To test the safety of the drug combination and to see what kind of effects (good and bad) can be expected from the drug combination
- To measure visual changes before and after the study therapy
- To use a special MRI scan to measure brain function involved in vision processing, both before and after the study therapy
In this study, the investigators are also testing a new experimental way of giving carboplatin "subtenon carboplatin". The carboplatin will be given directly in the eye through a needle placed under the covering of the eye. This is to try to get more carboplatin to the retinoblastoma inside the eye.
Drug: subtenon Carboplatin
Drug: Topotecan Hydrochloride
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Intravenous Topotecan and Vincristine in Combination With Subconjunctival Carboplatin for Patients With a History of Bilateral Retinoblastoma and Refractory/Recurrent Intraocular Disease (IND# 104,942)|
- To estimate the event-free survival, where an event is defined at the ocular level as the need for non-protocol therapy defined as additional non-protocol chemotherapy, external beam radiation, or enucleation. [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
- To estimate the patterns of response, and response rate of locally refractory retinoblastoma to combination intravenous and peri-ocular chemotherapy. [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]
- To describe the toxicities associated with the proposed regimen. [ Time Frame: at 1 yr ] [ Designated as safety issue: Yes ]
- To describe the histologic findings in the eyes ultimately requiring enucleation. [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]
- To describe the visual acuity of patients with advanced intraocular retinoblastoma before and after the proposed therapy. [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]
- To describe primary visual cortex function in patients with retinoblastoma via functional Magnetic Resonance Imaging (fMRI) technique both before and after the proposed therapy. [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
|Experimental: Topotecan/Vincristine with subtenon Carboplatin||
Drug: subtenon Carboplatin
Available in 50mg, 150mg, 450 mg, 600mg vials. It is provided as a premixed aqueous solution or lyophilized powder for injection given on day 1/week 10 (cycles 1-3).
Other Name: ParaplatinDrug: Topotecan Hydrochloride
Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base. Given intravenously on days 1-5 of each week (cycles 1-6).
Other Name: HycamtinDrug: Vincristine
Each vial contains vincristine sulfate, 1 mg; mannitol, 100 mg; sterile water for injection; Acetic acid and sodium acetate are added for pH control. Given intravenously on day 1/week 1 (cycles 1-6).
Other Name: OncovinDrug: Filgrastim
Supplied as a clear solution in 300 mcg/ml 1 ml or 1.6 ml vials and prefilled syringes containing 300mcg/0.5mL or 480mcg/0.8mL. Given intravenously on day 6 of each week (cycles 1-6).
Other Name: Neupogen
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980551
|Contact: James Geller, MD||(513) 636-6312||James.Geller@cchmc.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: James Geller, MD 513-636-6312 James.Geller@cchmc.org|
|Principal Investigator: James Geller, MD|
|Principal Investigator:||James Geller, MD||Children's Hospital Medical Center, Cincinnati|