71 Participants Needed

Combination Chemotherapy + Cyclosporine and Focal Therapy for Retinoblastoma

Recruiting at 5 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: The Hospital for Sick Children
Must be taking: Cyclosporine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cyclosporine together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Cryotherapy kills tumor cells by freezing them. Laser therapy uses light to kill tumor cells. Giving combination chemotherapy together with cyclosporine followed by cryotherapy and/or laser therapy may be an effective treatment for retinoblastoma.PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with cyclosporine followed by cryotherapy and/or laser therapy works in treating patients with newly diagnosed retinoblastoma in both eyes.

Who Is on the Research Team?

HS

Helen SL Chan, MD, BS

Principal Investigator

The Hospital for Sick Children

EH

Elise Heon, MD

Principal Investigator

The Hospital for Sick Children

BL

Brenda L Gallie, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

IIRC Group E disease in 1 eye allowed provided the eye was enucleated at diagnosis AND there is no extraocular RB in the enucleated eye by histologic confirmation AND there is IIRC Group B, C, or D disease in the remaining eye
Age over 30 days
AST and ALT < 2 times upper limit of normal (ULN)
See 6 more

Exclusion Criteria

You have a type of eye cancer called retinoblastoma that has spread outside of the eye.
IIRC Group A disease in 1 or both eyes
Unilateral RB
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose carboplatin, etoposide, vincristine, and cyclosporine chemotherapy followed by focal therapy with cryotherapy and/or laser therapy

9-18 weeks
Every 3 weeks for 3-6 cycles

Focal Therapy

Participants undergo additional cryotherapy and/or laser therapy for tumor consolidation

Up to 5 years as needed
Every 4-8 weeks or longer intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 3 months for 2 years, every 6 months for 2 years, then annually for 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Cryosurgery
  • Cyclosporine
  • Etoposide
  • Laser Therapy
  • Vincristine sulfate
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: CEV Chemo + Cyclosporine & Focal TherapyExperimental Treatment7 Interventions

Carboplatin is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Paraplatin for:
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Approved in European Union as Carboplatin for:
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Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

Terry Fox Foundation

Collaborator

Trials
8
Recruited
4,400+
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