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Topoisomerase I inhibitor
Topotecan Episcleral Plaque for Retinoblastoma
Phase 1
Waitlist Available
Research Sponsored by Targeted Therapy Technologies, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Unilateral Group D or earlier-stage intraocular retinoblastoma in which enucleation is a recommended therapy, with no previous local or systemic therapy for retinoblastoma with intraocular calcium in the tumor-containing eye by ophthalmic ultrasound or neuroimaging.
Organ Function Requirements:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
Study Summary
This trial will assess the safety and efficacy of episcleral topotecan in patients with retinoblastoma who have completed first-line therapy.
Who is the study for?
This trial is for children and young adults under 21 with retinoblastoma in at least one eye, who have completed first-line therapy. They must have potential vision in the affected eye and meet specific health criteria including adequate bone marrow, kidney, and liver function. Females of childbearing age must use effective contraception.Check my eligibility
What is being tested?
The safety and effectiveness of a treatment called episcleral topotecan are being tested on patients with active de novo or recurrent intraocular retinoblastoma. It's a phase I trial where doses will be increased to find the safest dose that can also potentially help treat the cancer.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions to chemotherapy such as nausea, fatigue, low blood counts leading to an increased risk of infection or bleeding, kidney or liver issues depending on individual tolerance to topotecan.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have early-stage retinoblastoma in one eye and haven't had treatment for it.
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My organs are functioning well.
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I can do most activities by myself, regardless of my age.
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My bilirubin levels are within the normal range for my age.
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My eye tumor shows calcium deposits on an ultrasound or MRI.
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I am younger than 21 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the safety and tolerability of Episcleral Topotecan in participants with retinoblastoma-Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D).
Secondary outcome measures
To determine systemic exposure by measurement of Topotecan in plasma.
To preliminarily define the antitumor activity as determine by assessments of tumor reponse;
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase I Open Label StudyExperimental Treatment1 Intervention
Phase I Single Arm
Find a Location
Who is running the clinical trial?
Targeted Therapy Technologies, LLCLead Sponsor
3 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow is working well.One of my eyes, the one more affected by retinoblastoma or with better vision potential, will be treated in the study.I have active eye cancer despite having initial treatment.There is evidence that the cancer has spread beyond the eyes.My organs are functioning well.I am not pregnant or breastfeeding, or I have stopped breastfeeding to join the study.My scans show possible or confirmed spread of eye cancer to the optic nerve or beyond.My hemoglobin level is at least 8.0 g/dL, transfusions are okay.My kidney function, based on my age and gender, is within the required range.My affected eye can sense light and shows no signs of cancer spreading outside the eye.My platelet count is above 100,000 and I haven't had a transfusion in the last week.I have early-stage retinoblastoma in one eye and haven't had treatment for it.I understand the study and agree to participate by signing the consent form.I can do most activities by myself, regardless of my age.I haven't had chemotherapy or other specific eye cancer treatments in the last 3 weeks.My bilirubin levels are within the normal range for my age.My kidney function, measured by creatinine levels, is within the normal range for my age and gender.My kidney function is normal.My eye tumor shows calcium deposits on an ultrasound or MRI.My tumor affects the edge of my optic nerve.My retinoblastoma has spread beyond my eye.My liver is working well.My condition does not match any known exclusion criteria.I am younger than 21 years old.I have been diagnosed and am seeking treatment.I have not had a significant fever or illness in the last week.I am 6 years old.Children between the ages of 2 and less than 6 years old are eligible.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Open Label Study
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.
In what situations is Episcleral Topotecan commonly utilized?
"Topotecan is a common drug used to treat ovarian cancer, with additional applications in leukemias, acute myelocytic sarcomas and other malignant neoplasms."
Answered by AI
How hazardous is Episcleral Topotecan to individuals' health?
"Due to the limited safety and efficacy data in Phase 1 trials, our team at Power has rated Episcleral Topotecan's safety as a score of 1."
Answered by AI
Is enrollment for this trial still taking place?
"Affirmative, the information hosted on clinicaltrials.gov reveals that this experiment is still enrolling patients as of June 29th 2022. This project was initially posted on 16th June 2021 and requires 30 individuals to be recruited across 2 sites."
Answered by AI
How many participants are a part of this clinical experiment?
"Indeed, the clinicaltrials.gov website confirms that enrollment for this medical trial is still open; it was initially posted on June 16th 2021 and last amended on June 29th 2022. Altogether, 30 patients must be recruited from two different healthcare facilities."
Answered by AI
What other investigative endeavors have been conducted with Episcleral Topotecan?
"Currently, 61 clinical trials are underway for Episcleral Topotecan. Of these studies, 17 have reached Phase 3 on the development timeline. While Sioux Falls, South dakota houses a majority of them, there exists an expansive network of trial sites spread across 3192 locations."
Answered by AI
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