Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma

Summary

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.

Conditions

• Retinoblastoma

Interventions

BIOLOGICAL

filgrastim

Given after chemo cycle for 7 days or until neutrophil counts return to normal.

DRUG

Carboplatin

Given at 28 mg/kg/dose.

DRUG

Cyclosporine

Given at 33 mg/kg/dose

DRUG

Etoposide

Given at 12 mg/kg/dose

DRUG

vincristine sulfate

Given at 0.025 mg/kg/dose for the first cycle and 0.05 mg/kg/dose for subsequent cycles if first cycle well-tolerated

PROCEDURE

cryosurgery

Local application of extreme cold to destroy residual tumor.

PROCEDURE

laser therapy

Local and precise application of laser beams to destroy residual tumor.

Sponsors & Collaborators

• Terry Fox Foundation

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Brenda L Gallie, MD · The Hospital for Sick Children

• Elise Heon, MD · The Hospital for Sick Children

• Helen SL Chan, MD, BS · The Hospital for Sick Children

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-06-30

Primary Completion

2016-04-20

Completion

2024-12-31

Countries

• Canada
• Chile
• India
• Singapore

Study Locations