Retinoblastoma Clinical Trial
Official title:
Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma
Verified date | February 2020 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Retinoblastoma (RB) is the most common intraocular tumor of childhood. Recurrent or
refractory disease following therapy most often occurs due to persistence of vitreous disease
and/or retinal reactivation of the main tumor mass. With this treatment protocol,
investigators seek to identify a less invasive method of local drug delivery that does not
disrupt the eye's integrity.
PRIMARY OBJECTIVE:
- To determine the safety and toxicity profile associated with intravitreal carboplatin
for the treatment of recurrent or progressive intraocular retinoblastoma with vitreous
seeding.
SECONDARY OBJECTIVES:
- To estimate the ocular salvage rate after treatment with intravitreal carboplatin in
patients with recurrent or progressive intraocular retinoblastoma with vitreous seeding.
- To evaluate the effects of intravitreal carboplatin therapy on the histopathology of
eyes enucleated for progressive or recalcitrant disease while on therapy.
Status | Completed |
Enrollment | 8 |
Est. completion date | October 4, 2019 |
Est. primary completion date | October 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
Eligibility |
Inclusion Criteria: - Refractory or recurrent retinoblastoma with vitreous seeding meeting eligibility criteria by ultrasonic biomicroscopy performed during examination under anesthesia (EUA) by an ophthalmologist: - At least three consecutive clock hours of disease-free, attached peripheral retina through which the intraocular injection may be administered. - Absence of invasion in anterior and posterior chamber. - Absence of anterior hyaloid detachment. - Absence of retinal detachment at the entry site. - Absence of tumor at the entry site. - ECOG Performance Score must be = 2 within two weeks prior to registration. - Participants must have an adequate liver function, as defined by bilirubin =3 x upper limit of normal (ULN), and SGOT and SGPT =3 x ULN. - Participants must have adequate renal function as defined by serum creatinine =3 x ULN for age. - Legal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects. Legal guardians will be given a signed copy of the consent form. Exclusion Criteria: - Presence of metastatic disease or gross orbital involvement. - Participants must not have an invasive infection at time of protocol entry. - Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who develop dose-limiting toxicity (DLT) | DLTs are defined as any of the following: uveitis, sterile or infectious endophthalmitis, retinopathy or rhegmatogenous retinal detachment, massive vitreous hemorrhage that obscures direct visualization of the retina/tumor, and/or cataract that threatens the visual axis or view by treating physician. Grade 3 or 4 allergic reactions should lead to discontinuation of intravitreal carboplatin injections. Patients who have grade 3 or 4 allergic reactions will not be evaluable for this objective and will be replaced. |
From baseline through end of therapy (up to 5 months) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04564521 -
Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.
|
N/A | |
Recruiting |
NCT02933333 -
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
|
Phase 4 | |
Withdrawn |
NCT01151748 -
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
|
Phase 2 | |
Completed |
NCT01048892 -
Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
|
Phase 1 | |
Active, not recruiting |
NCT00360750 -
Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye
|
N/A | |
Completed |
NCT00003173 -
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
|
Phase 2 | |
Enrolling by invitation |
NCT06227962 -
Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors
|
||
Completed |
NCT01661400 -
Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors
|
Phase 1 | |
Terminated |
NCT02617862 -
PCI Imaging System in Pediatric Ophthalmology
|
N/A | |
Recruiting |
NCT02329002 -
SPT Screening in Irradiated Hereditary Retinoblastoma Survivors
|
N/A | |
Terminated |
NCT01466855 -
A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma
|
Early Phase 1 | |
Completed |
NCT01505569 -
Auto Transplant for High Risk or Relapsed Solid or CNS Tumors
|
N/A | |
Completed |
NCT00002515 -
Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer
|
Phase 2 | |
Enrolling by invitation |
NCT03655223 -
Early Check: Expanded Screening in Newborns
|
||
Completed |
NCT06367569 -
Evaluation of MRI of the Pineal Gland in Retinoblastoma
|
||
Completed |
NCT02193724 -
Feasibility of Generating Pluripotent Stem Cells From Patients With Familial Retinoblastoma
|
||
Completed |
NCT01884194 -
Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging
|
N/A | |
Terminated |
NCT01393769 -
Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular Stage
|
Phase 2 | |
Completed |
NCT00006246 -
Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
|
Phase 1 | |
Terminated |
NCT00003926 -
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors
|
Phase 1 |