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Alkylating agents
Carboplatin + Topotecan for Retinoblastoma
Phase 2
Waitlist Available
Led By Carlos Rodriguez-Galindo, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have an adequate liver function, as defined by bilirubin ≤ to 3X upper limit of normal (ULN), and SGOT and SGPT ≤ to 3X ULN.
Participants must have adequate renal function as defined by serum creatinine ≤ to 3X ULN for age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after two upfront courses of chemotherapy (approximately two months after patient enrollment)
Awards & highlights
Study Summary
This trial is studying how well carboplatin and topotecan work when given together in treating patients with retinoblastoma.
Who is the study for?
This trial is for children with newly diagnosed, untreated intraocular retinoblastoma. It includes those who had unilateral retinoblastoma and now have it in the other eye. They must be able to perform daily activities (ECOG ≤ 2) and have normal kidney and liver function. Those with previous treatments, metastatic disease, active infections or unable to consent are excluded.Check my eligibility
What is being tested?
The study tests how well advanced intraocular retinoblastoma responds to direct-eye chemotherapy (carboplatin) plus systemic topotecan. It also uses various therapies like cryotherapy, thermotherapy, radiation therapy, surgery or enucleation if necessary while trying to preserve vision.See study design
What are the potential side effects?
Possible side effects include reactions from chemotherapy drugs like nausea, hair loss, low blood counts leading to infection risk; damage from radiation; pain or complications from surgical procedures; and potential vision loss depending on treatment type.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver functions within normal limits.
Select...
My kidney function is within the normal range for my age.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after two upfront courses of chemotherapy (approximately two months after patient enrollment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after two upfront courses of chemotherapy (approximately two months after patient enrollment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate (complete or partial response)
Secondary outcome measures
Event-free survival
The mechanism (or frequencies) for each RB1 biallelic inactivation
ocular survival
Side effects data
From 2014 Phase 3 trial • 361 Patients • NCT0097691131%
Neutropenia
27%
Fatigue
20%
Anaemia
18%
Peripheral sensory neuropathy
17%
Hypertension
13%
Leukopenia
13%
Mucosal inflammation
12%
Proteinuria
11%
Infection
11%
Palmar-plantar erythrodysaesthesia syndrome
9%
Abdominal pain
9%
Diarrhoea
9%
Nausea
8%
Urinary tract infection
8%
Vomiting
8%
Alopecia
7%
Constipation
6%
Thrombocytopenia
6%
Dyspnoea
6%
Weight decreased
6%
Decreased appetite
5%
Abdominal pain upper
5%
Epistaxis
2%
Pyrexia
2%
Subileus
2%
Ileus
2%
General physical health deterioration
1%
Shock
1%
Venous thrombosis
1%
Influenza like illness
1%
Breast cancer
1%
Hypertransaminasaemia
1%
Bacteraemia
1%
Ischaemic stroke
1%
Posterior reversible encephalopathy syndrome
1%
Embolism venous
1%
Intestinal perforation
1%
Small intestinal obstruction
1%
Intestinal obstruction
1%
Gastroenteritis
1%
Bone pain
1%
Hypertensive crisis
1%
Myocardial ischaemia
1%
Catheter site necrosis
1%
Syncope
1%
Arterial occlusive disease
1%
Deep vein thrombosis
1%
Embolism arterial
1%
Sepsis
1%
Wrong drug administered
1%
Tooth abscess
1%
Bone disorder
1%
Nephrotic syndrome
1%
Skin ulcer
1%
Device related infection
1%
Dehydration
1%
Vesical fistula
1%
Female genital tract fistula
1%
Pleural effusion
1%
Pneumonia aspiration
1%
Gastrointestinal haemorrhage
1%
Haemorrhagic ascites
1%
Ileal perforation
1%
Ileal stenosis
1%
Infectious peritonitis
1%
Postoperative wound infection
1%
Pulmonary embolism
1%
Cardiac arrest
1%
Coronary artery disease
1%
Coronary artery stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy + Bevacizumab
Chemotherapy
Trial Design
4Treatment groups
Experimental Treatment
Group I: Stratum DExperimental Treatment9 Interventions
Participants with bilateral retinoblastoma who may require upfront enucleation for one eye due to advanced disease (R-E IV-V and IC E).
Interventions (see Detailed Description): vincristine, carboplatin, topotecan, etoposide, enucleation, filgrastim or PEG-filgrastim, focal therapy, including cryotherapy, laser photocoagulation, thermotherapy (and thermo-chemotherapy) and episcleral plaque brachytherapy, and external beam radiation or proton beam radiation in select cases.
Group II: Stratum CExperimental Treatment9 Interventions
Participants with advanced (R-E IV-V and IC D-E) unilateral retinoblastoma who require upfront enucleation. Participants will be assessed and treated by low, intermediate or high risk.
Interventions (see Detailed Description): vincristine, cyclophosphamide, MESNA, doxorubicin, etoposide, carboplatin, filgrastim or PEG-filgrastim, enucleation
Group III: Stratum BExperimental Treatment7 Interventions
Participants considered candidates for conservative management including those:
Participants with bilateral retinoblastoma who have R-E IV-V and IC D in one eye
Participants with advanced unilateral (unifocal or multifocal) retinoblastoma (R-E IV-V and IC D-E) who demonstrate foveal sparing by the tumor during EUA. Due to foveal sparing, these patients have potential for vision preservation.
Interventions (see Detailed Description): vincristine, topotecan, carboplatin, etoposide, filgrastim or PEG-filgrastim and focal therapy, including cryotherapy, laser photocoagulation, thermo-therapy, plaque radiotherapy.
Group IV: Stratum AExperimental Treatment6 Interventions
Participants with early bilateral or unilateral (unifocal or multifocal) retinoblastoma (R-E I-III, IC A-B; R-E IV with IC A or B; or IC C with limited sub-retinal seeding), and participants with bilateral disease in whom the advanced eye has been enucleated upfront (without any high risk histopathology) and the remaining eye has early stage disease (as defined above).
Interventions (see detailed description): vincristine, carboplatin, topotecan, filgrastim or PEG-filgrastim, and focal therapy, including cryotherapy, laser photocoagulation, thermo-therapy, plaque radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MESNA
2004
Completed Phase 2
~60
carboplatin
2010
Completed Phase 3
~4790
doxorubicin
2005
Completed Phase 3
~9130
etoposide
1994
Completed Phase 3
~9300
vincristine
2005
Completed Phase 4
~3840
topotecan
2009
Completed Phase 3
~870
filgrastim
1997
Completed Phase 3
~7260
cyclophosphamide
1994
Completed Phase 3
~8140
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,439 Total Patients Enrolled
9 Trials studying Retinoblastoma
4,490 Patients Enrolled for Retinoblastoma
Carlos Rodriguez-Galindo, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
6 Previous Clinical Trials
1,850 Total Patients Enrolled
3 Trials studying Retinoblastoma
319 Patients Enrolled for Retinoblastoma
Rachel C. Brennan, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Retinoblastoma
15 Patients Enrolled for Retinoblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been mostly active and able to care for myself in the last two weeks.My cancer has spread to other parts of my body or affects my eye socket.I do not have a serious infection right now.I have a new, untreated eye cancer or my other eye has now been affected.My liver functions within normal limits.My kidney function is within the normal range for my age.
Research Study Groups:
This trial has the following groups:- Group 1: Stratum D
- Group 2: Stratum C
- Group 3: Stratum A
- Group 4: Stratum B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the topotecan success rate according to the FDA?
"While there is some data supporting topotecan's safety, it remains unproven whether the medication is effective. Our team at Power gave it a 2."
Answered by AI
How many people are receiving care as part of this investigation?
"That is accurate. The listing for this clinical trial on clinicaltrials.gov says that it is open and recruiting patients. This particular trial was created on 6/19/2013 and edited most recently on 8/25/2022; at the moment, they are looking to enroll 200 individuals from a single site."
Answered by AI
What type of cancer does topotecan typically target?
"topotecan is most commonly used to treat merkel cell cancer; however, it can also be an effective treatment for leukemia, initial stages of prostate cancer, etc."
Answered by AI
Are new patients being signed up for this experiment currently?
"That is accurate, the clinical trial is recruiting patients currently. According to the information available on clinicaltrials.gov, this study was first posted on 6/19/2013 and was last edited on 8/25/2022. They are looking for 200 participants total from 1 location."
Answered by AI
What are the most recent findings on topotecan?
"At the moment, there are 1807 clinical trials ongoing that are researching topotecan. 424 of those active trials are in Phase 3. Most of the trials for topotecan are based in Bethesda, Maryland, but there are 77769 locations running studies for this treatment globally."
Answered by AI
Is this research article the first of its kind?
"There are 1807 ongoing studies involving topotecan across 3649 cities and 85 countries. The earliest study for topotecan was conducted in 1997 by Alfacell, which reached Phase 3 approval after enrolling 300 participants. Since then, 2770 additional studies have been completed."
Answered by AI
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