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| ID | Type | Description | Link |
|---|---|---|---|
| HFSC-OCRN-RB-2003 | Other Identifier | The Hospital for Sick Children | |
| CDR0000422340 | Other Identifier | The Hospital for Sick Children |
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| Name | Class |
|---|---|
| Terry Fox Foundation | OTHER |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive high-dose carboplatin IV over 30 minutes on day 1; vincristine IV over 5 minutes and high-dose etoposide IV over 25 minutes on day 2; cyclosporine IV over 1 hour before chemotherapy and then over 2 hours after chemotherapy on days 1 and 2, and filgrastim (G-CSF) subcutaneously once daily beginning on day 3 and continuing until day 16 or until blood counts recover. Treatment repeats every 21 days for a total of 3 courses for patients with Group B disease and a total of 6 courses for patients with Group C or D disease.
Patients undergo eye examination under anesthesia (EUA) at initial staging and then before each course of chemotherapy. Patients with small peripheral tumors in eyes without retinal detachment undergo minimal focal therapy (mainly cryotherapy) during EUA at initial staging and then after chemotherapy courses 1 and 2. At EUA after the third and subsequent courses of chemotherapy, patients with tumors that have sufficiently reduced in size undergo additional cryotherapy or laser therapy. After completion of chemotherapy, patients with any suspicious, active, or reactivated tumor undergo additional cryotherapy and/or laser therapy during EUA approximately every 4-8 weeks (or at longer intervals) for up to 5 years (as needed).
After completion of study chemotherapy, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for 1 year.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2.4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEV Chemo + Cyclosporine & Focal Therapy | Experimental | Systemic carboplatin (28 mg/kg/dose), etoposide (12 mg/kg/dose) and vincristine sulfate (0.025 mg/kg/dose for the first cycle and 0.05 mg/kg/dose for subsequent cycles if first cycle well-tolerated) chemotherapy given with cyclosporin A (33 mg/kg/dose). Following 4-6 cycles CEV chemotherapy (depending on tumor stage) given every 3 weeks, focal laser therapy and/or cryosurgery are applied for tumor consolidation. Filgrastim is given after each chemotherapy cycle to prevent severe neutropenia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | Given after chemo cycle for 7 days or until neutrophil counts return to normal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing efficacy of study treatment with historic world data, in terms of increasing the proportion of eyes that remains relapse-free while avoiding external beam radiation and/or enucleation | Efficacy | 5 year follow-up per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity during treatment | Toxicity | 5 year follow-up per patient |
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>>INCLUSION CRITERIA<<
DISEASE CHARACTERISTICS:
Clinical diagnosis of bilateral intraocular retinoblastoma (RB)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Meets 1 of the following auditory criteria:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
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
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| Name | Affiliation | Role |
|---|---|---|
| Brenda L Gallie, MD | The Hospital for Sick Children | Principal Investigator |
| Elise Heon, MD | The Hospital for Sick Children | Principal Investigator |
| Helen SL Chan, MD, BS | The Hospital for Sick Children | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's and Women's Hospital of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada | ||
| Hospital for Sick Children |
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| Carboplatin | Drug | Given at 28 mg/kg/dose. |
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| Cyclosporine | Drug | Given at 33 mg/kg/dose |
|
| Etoposide | Drug | Given at 12 mg/kg/dose |
|
| vincristine sulfate | Drug | 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 |
|
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| cryosurgery | Procedure | Local application of extreme cold to destroy residual tumor. |
|
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| laser therapy | Procedure | Local and precise application of laser beams to destroy residual tumor. |
|
| Toronto |
| Ontario |
| M5G 1X8 |
| Canada |
| Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec | H3H 1P3 | Canada |
| Hospital San Juan de Dios | Santiago | 8500000 | Chile |
| Sankara Nethralaya Super Specialty Clinic | Chennai | 600 006 | India |
| Kandang Kerbau Women's and Children's Hospital | Singapore | 229899 | Singapore |
| ID | Term |
|---|---|
| D012175 | Retinoblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D016190 | Carboplatin |
| D016572 | Cyclosporine |
| D005047 | Etoposide |
| D014750 | Vincristine |
| D003452 | Cryosurgery |
| D017679 | Cryotherapy |
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
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