Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Terry Fox Foundation
• Treatments: Carboplatin; Cyclosporine; Cyclosporins; Etoposide; Etoposide phosphate; Lenograstim; Sargramostim; Vincristine

Criteria

>>INCLUSION CRITERIA<<

DISEASE CHARACTERISTICS:

• Clinical diagnosis of bilateral intraocular retinoblastoma (RB)

• International Intraocular Retinoblastoma Classification (IIRC) Group B, C, or D disease in 1 or both eyes

• 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

PATIENT CHARACTERISTICS:

Age

• Over 30 days

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• AST and ALT < 2 times upper limit of normal (ULN)

• Conjugated and unconjugated bilirubin < 2 times ULN

Renal

• Creatinine < 1.5 times ULN

• Glomerular filtration rate (GFR) ≥ 100 mL/min* NOTE: *A 4-hour IV hydration is allowed if GFR is low due to poor hydration or transient dehydration

Other

• Meets 1 of the following auditory criteria:

• Normal audiogram

• At least normal responses to speech by audiogram

• Documentation of hearing by acoustic emission test

• Recording of evoked potentials by auditory brain stem response

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

>>EXCLUSION CRITERIA<<

• IIRC Group A disease in 1 or both eyes

• unilateral RB

• extraocular or metastatic RB

• younger than 30 days

• Glomerular filtration rate (GFR) < 100 mL/min