Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma (RELRB1)
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
|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|