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Alkylating agents
Individualized Therapy for Retinoblastoma
Phase 3
Waitlist Available
Led By Ibrahim Qaddoumi, M.D.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients were assessed at 5 years of age
Awards & highlights
Study Summary
This trial is investigating how children with retinoblastoma respond to different individualized therapies. The main goal is to cure the cancer and save the child's life, while also saving their vision.
Who is the study for?
This trial is for children with newly diagnosed retinoblastoma, a type of eye cancer. They must have good liver and kidney function, be expected to live at least 8 weeks, and have a performance status showing they can do some daily activities. Kids who've had surgery or focal treatments on one eye but then get cancer in the other are also eligible. Children with spread of cancer outside the eye or an active infection cannot join.Check my eligibility
What is being tested?
The study tests various treatments based on whether one or both eyes are affected and how advanced the disease is. It includes chemotherapy combinations like topotecan and vincristine (with G-CSF support), carboplatin around the eye, plus potential surgeries and focal therapies like laser treatment. The aim is to cure cancer, save vision, understand how kids adapt visually post-treatment, and learn more about retinoblastoma biology.See study design
What are the potential side effects?
Treatments may cause side effects such as reactions from chemotherapy drugs including nausea, hair loss, increased risk of infections due to low blood cell counts (from G-CSF), liver issues indicated by abnormal blood tests results (bilirubin/SGOT/SGPT levels), fatigue from radiation therapy; specific side effects will depend on individual responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients were assessed at 5 years of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients were assessed at 5 years of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stratum B Response to Window Therapy
Secondary outcome measures
Assessment of School Readiness
Change in Cognitive Functioning
Change in Distortion Product Otoacoustic Emissions (DPOAEs)
+26 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Stratum CExperimental Treatment5 Interventions
Patients with advanced unilateral advanced intraocular disease. First intervention is enucleation.
If enucleated eye does not have disease outside the retina (low risk), no additional treatment is given.
For patients whose enucleated eye shows tumor outside the retina (intermediate risk), they will receive 4 courses of vincristine, cyclophosphamide, and doxorubicin followed by G-CSF.
For patients with high risk disease (involvement of the sclera, optic nerve at the level of the cut-end), treatment after enucleation is 6 courses of alternating chemotherapy with vincristine, carboplatin, etoposide (VCE) to alternate with vincristine, cyclophosphamide, and doxorubicin (VCD). High risk patients also receive external-beam radiation therapy.
Group II: Stratum BExperimental Treatment8 Interventions
Patients with bilateral disease (at least one advanced stage eye), candidate for conservative management.
Treatment included window treatment with vincristine and topotecan, Followed by 3 more courses of vincristine-topotecan if they had a response to the window+ 6 courses of vincristine and carboplatin. If they do not respond to the window, they receive 6 courses of vincristine, carboplatin, and etoposide. Periocular carboplatin is also given three times, depending on whether they respond to window. External Beam Radiation 44-46 Gy administered using standard practices.
Group III: Stratum AExperimental Treatment5 Interventions
Patients with early bilateral or unilateral, or patients with bilateral that have already had the advanced eye enucleated. Treatment included vincristine and carboplatin for 8 courses, given at 3-4 week intervals. Focal therapies any time after second course can include cryotherapy, laser photocoagulation, thermotherapy, and plaque radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation
2014
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
427 Previous Clinical Trials
5,306,470 Total Patients Enrolled
9 Trials studying Retinoblastoma
4,557 Patients Enrolled for Retinoblastoma
National Cancer Institute (NCI)NIH
13,655 Previous Clinical Trials
40,933,112 Total Patients Enrolled
23 Trials studying Retinoblastoma
11,562 Patients Enrolled for Retinoblastoma
Ibrahim Qaddoumi, M.D.Principal InvestigatorSt. Jude Children's Research Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a serious infection right now.I have a new diagnosis of eye cancer and haven't been treated, or I had treatment for cancer in one eye and now the other is affected.I am able to get out of my bed or chair and move around.Patients who have received treatment for this condition before.My kidney function is within the normal range for my age.My liver functions within normal limits according to my recent tests.My cancer has spread to other parts of my body or affects my eye socket.
Research Study Groups:
This trial has the following groups:- Group 1: Stratum A
- Group 2: Stratum C
- Group 3: Stratum B
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Is this treatment based on previous research?
"At the moment, there are 1739 active clinical trials studying this treatment. Out of those, 415 are in Phase 3. The majority of the clinical trials related to this treatment are located in Bethesda, Maryland; however, there are a total of 76174 locations running studies for this treatment."
Answered by AI
Does this trial use an innovative design?
"There are 1,739 open trials for this treatment in 84 countries and 3,626 cities. The first trial was conducted in 1997 by Alfacell and completed Phase 3 drug approval with 300 patients. Since then, there have been 2,485 additional studies."
Answered by AI
Does this medication adhere to FDA guidelines?
"This Phase 3 trial has provided some evidence of efficacy, and there is supporting safety data from multiple rounds of testing, so our team at Power estimates the safety of the treatment to be a 3."
Answered by AI
Is there still an opportunity to join this clinical trial as a test subject?
"This particular trial is not currently looking for participants, as it was last edited on January 10th, 2022. However, there are presently 29 other studies related to retinoblastoma that are actively recruiting patients as well as 1,739 other trials for this treatment."
Answered by AI
How many people can be enrolled in this clinical trial at most?
"Recruitment for this particular trial has closed, however, there are 29 other clinical trials for retinoblastoma and 1739 other trials for this treatment that are still recruiting patients."
Answered by AI
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