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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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free Survival (EFS)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Cisplatin

2013

Completed Phase 3

~3120

In Vitro-Treated Peripheral Blood Stem Cell Transplantation

2010

Completed Phase 2

~70