Clinical trial · Interventional
Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma
Multicenter Phase II Study for International Intraocular Retinoblastoma Classification Groups B, C & D Tumors Treated With Carboplatin-Etoposide-Vincristine-Cyclosporine-Focal Therapy Multimodality Protocol (OCRN Multicenter RB 2003)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| cryosurgery | Procedure | — | UNRESOLVED |
| Cyclosporine | Drug | — | UNRESOLVED |
| Etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| laser therapy | Procedure | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CEV Chemo + Cyclosporine & Focal Therapy
- description
- 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.
- interventionNames
- Biological: filgrastim
- Drug: Carboplatin
- Drug: Cyclosporine
- Drug: Etoposide
- Drug: vincristine sulfate
- Procedure: cryosurgery
- Procedure: laser therapy
Primary outcomes (1)
- measure
- 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
- timeFrame
- 5 year follow-up per patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Days
Show eligibility criteria text
\>\>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
References
Publications (0)
Data not yet available