Active, not recruiting
Phase 2
Conservative Treatments of Retinoblastoma
Condition(s) studied
RetinoblastomaChildrenRetinal Neoplasm
Investigational drug(s) / intervention(s)
VP16, carboplatin: Systemic treatment : Intravenous injections, 2 cycles (21 days)
Melphalan: intraarterial injections, 3 to 6 cycles (1 month)
VP16, carboplatin, vincristin: Systemic treatment : Intravenous injections, 6 cycles (21 days)
Carboplatin + laser day 1 (chemothermotherapy): Chemothermotherapy : Intravenous injection by carboplatin and Laser at day 1
Study summary
Conservative treatments of retinoblastoma (RETINO 2011)
1. -Multicentric non randomised, phase II study for the patients treated by chemoreduction (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8
2. -Multicentric non randomised, phase II study for the patients with bilateral very asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups B/C/D according to the age and vitreous seeding
3. \- Multicentric non randomised, phase II study for the patients treated by 6 cycles of three drugs regimen and local treatments for bilateral group D eyes or on the only eye.
Eligibility
Inclusion Criteria:
Study 1 inclusion criteria:
* Patients affected by unilateral retinoblastoma groups A, B (according to the age), group C (according to the age and vitreous seeding),or bilateral retinoblastoma groups A, B, C (excluding the eyes with macular threat and bilateral group D eyes or on the only remaining eye) amenable to a conservative treatment (at least on one eye in bilateral disease) but needing initial chemotherapy because of the location, the size of the lesion (more than 4 mm of diameter), a vision threat or risks of intravitreal relapse making those patients not amenable to chemothermotherapy first line.
* Patients less than six months of age with unilateral retinoblastoma groups B, C, D, or bilateral very asymmetric with one eye group D and the other amenable to local treatments without chemotherapy.
* Children from 0 to 6 years old.
Study 2 inclusion criteria:
* Patients affected by unilateral or bilateral retinoblastoma group B (according to the age), group C (according to the age and vitreous seeding), or group D.
* Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
* Children from 6 months to 6 years old.
Study 3 inclusion criteria:
* Children affected of bilateral group D retinoblastoma or on the only eye amenable to conservative treatment.
* Children from 0 to 6 years old.
Common inclusion criteria:
* Patients not previously treated by chemotherapy or radiotherapy for this tumour or another cancer.
* No contra-indications to the study treatments
* Possible long term follow-up.
* Written informed consent of the parents or the legal representative.
* Patients having social security cover.
Exclusion Criteria:
Study 1 exclusion criteria:
* Patients for whom a local treatment is possible without initial chemotherapy (tumour smaller than 4 mm and located far from optic nerve head or macula).
* Patients with an unilateral group D with massive tumour or group E eyes needing enucleation first line or after initial chemotherapy (in case of buphthalmia or suspected optic nerve invasion or extrascleral extension).
* Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
* Patients with bilateral retinoblastoma and bilateral group D eyes or on the only remaining eye or presenting a bilateral macular threat requiring conservative treatment by a 6 cycles, three drugs regimen.
Study 2 exclusion criteria:
* Patients with a unilateral group D (extensive) or B or C but covering the optic nerve head or group E eyes for which enucleation is warranted first line or after chemotherapy (in case of buphthalmia or suspected optic nerve invasion or extrascleral extension).
* Patients with unilateral group D eye with tumour volume of more than 50% of eye volume, for whom a massive choroidal invasion could be associated (on clinical or imaging criteria) and for which enucleation is warranted.
Study 3 exclusion criteria:
* Patients for whom a local treatment is possible without chemoreduction (tumour smaller than 4 mm, distant from macula and from optic nerve head).
* Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
* Patients with bilateral retinoblastoma without macular threat or groups A, B, C than can be treated with chemoreduction by VP16 and Carboplatin then chemothermotherapy without laser at day 8.
Common exclusion criteria:
* Patients older than 6 years old.
* Patients with extraocular retinoblastoma.
* Patients with a disease being a contra-indication to chemotherapy.
* Patients anteriorly treated by chemotherapy.
* Patients anteriorly treated by external beam irradiation.
* Patients anteriorly treated for another cancer.
* Follow-up not possible due to geographic distance from the center or for social or psychological reasons.
* Parents not having accepted the therapeutic strategy after explanations by the investigator.
* Contra-indication to the use of one of the drugs used in the study.
Primary outcome measure(s)
- Rate of enucleation and external beam irradiation — From first day of treatment to 18 months after the end of treatments
Trial sites (1)
| Facility | City | Region | Status |
| Institut Curie |
Paris |
France |
|
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