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Topoisomerase I inhibitor
Topotecan Episcleral Plaque for Retinoblastoma (STEP-RB Trial)
Phase 1
Recruiting
Led By Brenda Gallie
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study eye must have vision potential and no clinical features suggestive of high risk of extraocular extension
Lansky play score ≥ 50 if <16 years of age; Karnofsky performance scale of ≥ 50 if ≥16 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks
Awards & highlights
STEP-RB Trial Summary
This trial will assess the safety and efficacy of episcleral topotecan in patients with active residual or recurrent intraocular retinoblastoma.
Who is the study for?
Children under 18 with active residual or recurrent retinoblastoma in one eye after first-line therapy, or those newly diagnosed with certain types of retinoblastoma without prior treatment. They must have good organ function and performance status, and girls able to have children must use effective birth control. Kids can't join if they have cancer spread outside the eye, allergies to topotecan, other treatments within 3 weeks before the trial starts, uncontrolled illnesses, or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The safety and effectiveness of a new treatment called Topotecan Episcleral Plaque is being tested for kids with a type of eye cancer called retinoblastoma. This study involves gradually increasing doses to find out how much medicine can be given safely while checking how well it works against the cancer.See study design
What are the potential side effects?
Possible side effects may include reactions related to topotecan such as lowered blood cell counts which increases infection risk, potential liver or kidney issues due to drug processing in these organs. Specific side effects will be monitored closely during this early phase trial.
STEP-RB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My study eye can potentially see and doesn't show signs of cancer spreading outside the eye.
Select...
I can do most activities if under 16, or care for myself if 16 or older.
Select...
My eye cancer came back or didn't fully go away after first treatment.
Select...
I am under 18 years old.
STEP-RB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose and Recommended Phase 2 Dose of topotecan hydrochloride administered as a Chemoplaque to pediatric patients with active Retinoblastoma.
Secondary outcome measures
Tumor response to the Chemoplaque as secondary therapy in eye(s) with active retinoblastoma after completion of primary standard of care treatment.
Side effects data
From 2019 Phase 2 trial • 35 Patients • NCT0193109878%
Hypertension
67%
Fatigue
44%
Diarrhea
33%
Vomiting
33%
White blood cell decreased
33%
Cognitive disturbance
33%
Dysgeusia
33%
Seizure
33%
Nausea
22%
Weight loss
22%
Muscle weakness left-sided
22%
Anorexia
22%
Cough
22%
Gait disturbance
22%
Headache
22%
Neutrophil count decreased
22%
Pain
11%
Gastroesophageal reflux disease
11%
Musculoskeletal and connective tissue disorder - Other, specify
11%
Alanine aminotransferase increased
11%
Anemia
11%
Arthralgia
11%
Aspartate aminotransferase increased
11%
Bruising
11%
Depression
11%
Dizziness
11%
Dry mouth
11%
Dry skin
11%
Dysphagia
11%
Dysphasia
11%
Fall
11%
Flank pain
11%
Flu like symptoms
11%
Hematuria
11%
Hoarseness
11%
Hypernatremia
11%
Insomnia
11%
Lymphocyte count decreased
11%
Paresthesia
11%
Purpura
11%
Respiratory, thoracic and mediastinal disorders - Other, Congestion
11%
Sinus tachycardia
11%
Sinusitis
11%
Skin and subcutaneous tissue disorders - Other, Lacerations on legs
11%
Sore throat
11%
Spasticity
11%
Urinary urgency
11%
Oral pain
11%
Meningitis
11%
Eye disorders - Other, Left upper quadrant defect
11%
Gastrointestinal disorders - Other, specify
11%
Stroke
11%
Platelet count decreased
11%
Eye disorders - Other, Right Hemianops
11%
Hypoalbuminemia
11%
Hypocalcemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure
Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure
STEP-RB Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase I single arm trialExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
689 Previous Clinical Trials
6,945,391 Total Patients Enrolled
1 Trials studying Retinoblastoma
71 Patients Enrolled for Retinoblastoma
Brenda GalliePrincipal InvestigatorThe Hospital for Sick Children
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My study eye can potentially see and doesn't show signs of cancer spreading outside the eye.My kidneys are working well.My blood tests show my bone marrow and platelets are functioning well.I am allergic to topotecan, camptothecin, or similar drugs.I am not pregnant and will stop breastfeeding to start the treatment.One of my eyes is affected worse by retinoblastoma and will be the focus of the study.I haven't had chemotherapy or other specific treatments for retinoblastoma within the last 3 weeks.I agree to use effective birth control during and for 40 days after the study.I (or my guardian) can understand and am willing to sign the consent form.I can do most activities if under 16, or care for myself if 16 or older.My eye cancer came back or didn't fully go away after first treatment.My liver is working well.I am under 18 years old.My eye cancer has spread beyond the eye.I have a known metastatic disease and other ongoing health issues.I haven't had a fever or significant illness in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I single arm trial
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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 purpose does Topotecan Episcleral Plaque typically serve?
"Conventionaly, Topotecan Episcleral Plaque is employed to treat ovarian malignancy. It has also been approved for the treatment of acute myelocytic leukemia and various sarcomas and neoplasms."
Answered by AI
What is the aggregate population size participating in this experimental program?
"Affirmative. According to information hosted on clinicaltrials.gov, the research trial was made available for public access on June 16th 2020 and has since been revised as of May 18th 2021. At present, 30 participants must be found from a single medical centre in order to fulfil its recruitment requirements."
Answered by AI
How deleterious is the use of Topotecan Episcleral Plaque for patients?
"With a limited amount of data to support efficacy and safety, Topotecan Episcleral Plaque was rated 1 on our team's scale from 1 to 3."
Answered by AI
Is enrollment for this project currently available to participants?
"The listing on clinicaltrials.gov shows that the study is presently in search of patients, with initial posting occurring June 16th 2020 and a most recent update from May 18th 2021."
Answered by AI
Are there any precedents for the Topotecan Episcleral Plaque clinical trial?
"As of today, there are 61 active studies for Topotecan Episcleral Plaque. Of those trials, 17 have reached Phase 3 status and the majority can be found in Sioux Falls, South dakota - although a total of 3192 locations are conducting trials with this medication."
Answered by AI
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