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Alkylating agents

Combination Chemotherapy + Stem Cell Transplant/Radiation for Retinoblastoma

Phase 3

Waitlist Available

Led By Ira J Dunkel

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2

No prior chemotherapy or radiotherapy for the extra-ocular retinoblastoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

Study Summary

This trial is studying side effects and how well giving a combination of chemotherapy and either an autologous stem cell transplant or radiation therapy works in treating young patients with extraocular retinoblastoma.

Who is the study for?

This trial is for young patients with extraocular retinoblastoma, a type of eye cancer that has spread outside the eye. They should be in good physical condition (ECOG score 0-2), have not received prior treatment for this condition, and meet specific blood count and organ function criteria. Consent from patients or guardians is required.Check my eligibility

What is being tested?

The study tests how well combination chemotherapy works with autologous stem cell transplant and/or radiation therapy to treat these patients. The process involves using drugs to stop tumor growth, collecting the patient's own stem cells, giving more chemo to prepare for transplanting these cells back into the patient, followed by possible radiation therapy.See study design

What are the potential side effects?

Side effects may include damage to bone marrow resulting in low blood counts, increased risk of infections due to weakened immune system, potential kidney or liver issues from high drug doses used before stem cell transplant, nausea/vomiting from chemotherapy, and skin irritation from radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself and am up and about more than 50% of my waking hours.

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I have not had chemo or radiation for my eye cancer.

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My kidney function is normal or near normal.

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My cancer, starting in the retina, has been confirmed by tests and has spread beyond my eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Event-free Survival (EFS)

Secondary outcome measures

Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Response Rate to the Induction Phase of the Regimen

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy, radiotherapy, autologous SCI)Experimental Treatment11 Interventions

INDUCTION: Patients receive vincristine IV; cisplatin IV; cyclophosphamide IV; and G-CSF SC beginning on day 3 and continuing until blood counts recover. CONSOLIDATION (stage 4a or 4b disease only): Patients receive carboplatin IV; thiotepa IV; and etoposide IV. AUTOLOGOUS STEM CELL INFUSION (stage 4a or 4b disease only): Patients undergo autologous stem cell infusion on day 0 and receive G-CSF SC beginning on day 1 and continuing until blood counts recover. RADIOTHERAPY: Patients with stage 2 or 3 disease (orbital and/or regional involvement) undergo radiotherapy to sites that were initially involved beginning within 42 days after the start of course 4 of induction chemotherapy. Patients with stage 4a or 4b disease undergo radiotherapy to sites initially involved based on response beginning approximately 42 days after autologous stem cell infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

In Vitro-Treated Peripheral Blood Stem Cell Transplantation

2010

Completed Phase 2

~70

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

Filgrastim

2000

Completed Phase 3

~3670

Autologous Bone Marrow Transplantation

2013

Completed Phase 2

~660

Thiotepa

2008

Completed Phase 3

~2150

Vincristine Sulfate

2005

Completed Phase 3

~10110

Cyclophosphamide

1995

Completed Phase 3

~3780

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~1730

Etoposide

2010

Completed Phase 3

~2440

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,640 Total Patients Enrolled

8 Trials studying Retinoblastoma

900 Patients Enrolled for Retinoblastoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,093 Total Patients Enrolled

23 Trials studying Retinoblastoma

11,609 Patients Enrolled for Retinoblastoma

Ira J DunkelPrincipal InvestigatorChildren's Oncology Group

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00554788 — Phase 3

Retinoblastoma Research Study Groups: Treatment (chemotherapy, radiotherapy, autologous SCI)

Retinoblastoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00554788 — Phase 3

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00554788 — Phase 3

Frequently Asked Questions

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

Has the administration green-lit Filgrastim for public use?

"Filgrastim has been found to be safe in past clinical trials and thus, receives a score of 3."

Answered by AI

How many people fit the qualifications for this experiment?

"As of right now, this clinical trial is not actively looking for more patients. The original posting was on February 4th, 2008 and the most recent update was on July 8th, 2022. If you are interested in other studies, 29 trials for extraocular retinoblastoma and 2150 Filgrastim trials are still recruiting participants."

Answered by AI

Are there any patients currently enrolled in this trial?

"No, this study is not looking for new patients to enroll at the moment. The trial was originally posted on February 4th, 2008 and updated for the last time on July 8th, 20222. However, if you are interested in other studies, please note that there are 29 trials actively admitting patients with extraocular retinoblastoma and 2150 trials for Filgrastim currently recruiting participants."

Answered by AI

Are there comparable Filgrastim studies that have been completed?

"Filgrastim was first studied in 1997 and there have been a total of 3243 completed trials since. As of now, 2150 trials are still recruiting patients with a large majority being based out of Hartford, Connecticut."

Answered by AI

How is Filgrastim used to improve patient outcomes?

"Filgrastim is a medication used to commonly treat patients with merkel cell cancer. However, it can also be useful in helping those suffering from leukemia, initial treatment, and prostate cancer."

Answered by AI

Where are the different sites where this trial is taking place?

"The trial locations include, but are not limited to: Connecticut Children's Medical Center in Hartford, the University of Arkansas for Medical Sciences in Charlotte, Carolinas Medical Center/Levine Cancer Institute in Philadelphia. In total, there are 68 sites."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Intensive Multimodality Therapy for Extraocular Retinoblastoma: A Children's Oncology Group Trial (ARET0321)

Dunkel, Ira J., Jin Piao, Guillermo L. Chantada, Anuradha Banerjee, Sherif Abouelnaga, Jeffrey C. Buchsbaum, Thomas E. Merchant, et al.. 2022. “Intensive Multimodality Therapy for Extraocular Retinoblastoma: A Children's Oncology Group Trial (ARET0321)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.02337.

clinicaltrials.govStudy

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma

2008. "Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00554788.

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