Status:
ACTIVE_NOT_RECRUITING
Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Terry Fox Foundation
Conditions:
Retinoblastoma
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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 d...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy of neoadjuvant high-dose carboplatin and etoposide, vincristine, and cyclosporine (CSA) followed by ophthalmic focal therapy comprising cryotherapy and/or ...
Eligibility Criteria
Inclusion
- \>\>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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00110110
Start Date
June 1 2004
End Date
December 31 2024
Last Update
April 17 2024
Active Locations (6)
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1
Children's and Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
2
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
3
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3H 1P3
4
Hospital San Juan de Dios
Santiago, Chile, 8500000