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Alkylating agents

Combination Chemotherapy + Cyclosporine and Focal Therapy for Retinoblastoma

Phase 2

Waitlist Available

Led By Elise Heon, MD

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 year follow-up per patient

Awards & highlights

Study Summary

This trial is studying a combination of chemotherapy drugs with or without cyclosporine followed by cryotherapy (freezing) and/or laser therapy in treating patients with newly diagnosed retinoblastoma in both eyes.

Who is the study for?

This trial is for patients with bilateral retinoblastoma, a type of eye cancer, specifically those with IIRC Group B, C, or D disease in at least one eye. Suitable participants are over 30 days old and have normal liver and kidney function tests. Those with unilateral retinoblastoma, metastatic disease, or very young infants under 30 days old cannot join.Check my eligibility

What is being tested?

The study is testing if combining chemotherapy (carboplatin, etoposide, vincristine) with cyclosporine followed by cryotherapy or laser therapy can effectively treat retinoblastoma. Cyclosporine may help reduce the tumor's resistance to chemotherapy.See study design

What are the potential side effects?

Chemotherapy can cause side effects like nausea, hair loss, fatigue and increased risk of infection. Cryotherapy might lead to local pain or swelling. Laser therapy could potentially cause discomfort or damage to surrounding healthy tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 year follow-up per patient

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 year follow-up per patient

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 year follow-up per patient for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparing efficacy of study treatment with historic world data, in terms of increasing the proportion of eyes that remains relapse-free while avoiding external beam radiation and/or enucleation

Secondary outcome measures

Toxicity during treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: CEV Chemo + Cyclosporine & Focal TherapyExperimental Treatment7 Interventions

Systemic carboplatin (28 mg/kg/dose), etoposide (12 mg/kg/dose) and vincristine sulfate (0.025 mg/kg/dose for the first cycle and 0.05 mg/kg/dose for subsequent cycles if first cycle well-tolerated) chemotherapy given with cyclosporin A (33 mg/kg/dose). Following 4-6 cycles CEV chemotherapy (depending on tumor stage) given every 3 weeks, focal laser therapy and/or cryosurgery are applied for tumor consolidation. Filgrastim is given after each chemotherapy cycle to prevent severe neutropenia.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

cryosurgery

2007

Completed Phase 3

~110

vincristine sulfate

1994

Completed Phase 3

~11270

laser therapy

2008

Completed Phase 2

~550

Cyclosporine

1997

Completed Phase 3

~1830

Etoposide

2010

Completed Phase 3

~2440

filgrastim

1997

Completed Phase 3

~7260

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Terry Fox FoundationOTHER

7 Previous Clinical Trials

4,364 Total Patients Enrolled

The Hospital for Sick ChildrenLead Sponsor

692 Previous Clinical Trials

6,946,529 Total Patients Enrolled

1 Trials studying Retinoblastoma

30 Patients Enrolled for Retinoblastoma

Helen SL Chan, MD, BSStudy ChairThe Hospital for Sick Children

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00110110 — Phase 2

Retinoblastoma Research Study Groups: CEV Chemo + Cyclosporine & Focal Therapy

Retinoblastoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00110110 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00110110 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are currently enrolled in this project?

"At the present time, this clinical trial is not actively recruiting participants. The research was posted on June 1st 2004 and last updated May 3rd 2022. For individuals looking for alternative medical studies, 28 trials are currently enrolling people with retinoblastoma while 1173 related to filgrastim are being conducted."

Answered by AI

What experimental treatments have been conducted using filgrastim?

"Filgrastim's first instance of medical research occurred in 1997 at the City of Hope Comprehensive Cancer Center. Since then, 2144 trials have been concluded and 1173 are still running - notably, an abundance of these experiments are based out Vancouver, British Columbia."

Answered by AI

To what extent could filgrastim be detrimental to patients?

"The clinical data available for filgrastim suggests it is relatively safe, earning a safety rating of 2. While making strides in terms of safety, efficacy has yet to be established through any large-scale trials."

Answered by AI

What ailments are targeted by filgrastim therapies?

"Filgrastim is a common therapeutic choice when treating cyclic neutropenia. It also has demonstrated success in managing neuroendocrine tumours (NETs), ulcerative colitis, and liver conditions."

Answered by AI

Are there any open slots available in this clinical trial for participants?

"According to the clinicaltrials.gov's registry, this trial has concluded its recruitment process and is no longer actively seeking participants. This research was initially published in June 2004 and then last edited on May 3rd 2022. Despite this, there are still 1201 other trials currently open for enrolment right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma

Helen Chan 2004. "Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00110110.

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