Conservative Treatments of Retinoblastoma

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Conservative Treatments of Retinoblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 6 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02866136
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Curie
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Isabelle Aerts, MDCatherine Devoldere, MDIsabelle Pellier, MDVéronique Laithier, MDCeline De Bouyn-Icher, MDLiana-Stephania Carausau, MDDamien BODET, MDJustyna Kanold, MDClaire Briandet, MDDominique Plantaz, Prof.Hélène Sudour-Bonnange, MDChristophe Piguet, MDCécile Faure Conter, MDCarole Coze, MDNicolas Sirvent, MDLudovic Mansuy, MDEstelle Thebaud, MDMarilyne Dupuy-Poiree, MDFrederic Millot, MDClaire Pluchart, MDchloé Puiseux, MDPascale Schneider, Prof.Jean-Louis Stephan, Prof.Natacha Entz-Werle, MDAnne-Isabelle Bertozzi-Salamon, MDPascale BLOUIN, MDMichel Piotin, MD
Principal Investigator Affiliation	Institut Curie - Paris - FranceAmiens (FR), University College HospitalAngers (FR), University College HospitalBesançon (FR), Jean Minjoz HospitalBordeaux (FR), Pellegrin Regional HospitalBrest (FR), University College HospitalCaen (FR), University College HospitalClermont-Ferrand (FR), University College HospitalDijon (FR), Bocage University College HospitalGrenoble (FR), University College HospitalLille (FR), Oscar Lambret CenterLimoges (FR), University College HospitalLyon (FR), Leon Berard CenterMarseille (FR), La Timone Children HospitalMontpellier (FR), Arnaud de Villeneuve HospitalNancy (FR), University College HospitalNantes (FR), University College HospitalNice (FR), University College HospitalPoitiers (FR), University College HospitalReims (FR), Regional University College HospitalRennes (FR), University College HospitalRouen (FR), University College HospitalSaint-Etienne (FR), University College HospitalStrasbourg (FR), University College HospitalToulouse (FR), Children HospitalTours (FR), University College HospitalParis (FR), Adolphe Rothschild Ophtalmologic Foundation
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Retinoblastoma, Children, Retinal Neoplasm

Arms & Interventions

Arms

Other: (IV)Intravenous chemotherapy, laser diode

Group 1 - Multicentric non randomised, phase II study for patients with retinoblastoma (unilateral group A,B according to age, group C according to the age and the vitreous seeding or bilateral groups A,B and C excluding the bilateral groups D or patients with bilateral macular threat). Treatment by chemoreduction (VP16, carboplatin) followed by Carboplatin + laser day 1 (chemothermotherapy) without laser treatment at day 8 (decreasing laser sessions) combined to local treatments from third course (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan).

Other: (IA) Intraarterial Melphalan

Group 2 - Multicentric non randomised, phase II study for the patients with bilateral very asymmetric disease (group D retinoblastoma on one of the eye, and the other amenable to a local treatment without chemotherapy) or unilateral presentation group D and groups B/C according to the age and vitreous seeding. Treatment by Melphalan chemotherapy administered by superselective catheterization of the ophthalmic artery and combined to local treatments (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan).

Other: (IV-PM) Intravenous 3 drugs chemotherapy

Group 3 - Multicentric non randomised, phase II study for the patients with bilateral group D retinoblastoma or with a group D retinoblastoma on the only remaining eye. Treatment by 6 cycles of three drugs (VP16, carboplatin, vincristin) regimen combined to local treatments from the third cycle (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan).

Interventions

Drug: - VP16, carboplatin

Systemic treatment : Intravenous injections, 2 cycles (21 days)

Drug: - Melphalan

intraarterial injections, 3 to 6 cycles (1 month)

Drug: - VP16, carboplatin, vincristin

Systemic treatment : Intravenous injections, 6 cycles (21 days)

Drug: - Carboplatin + laser day 1 (chemothermotherapy)

Chemothermotherapy : Intravenous injection by carboplatin and Laser at day 1

Device: - Laser (local treatment)

Device: - cryoapplication (local treatment)

Radiation: - I125 radioactive plaques (local treatment)

Drug: - intravitreal Melphalan (local treatment)

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International Sites

Institut Curie, Paris, France

Status

Address

Institut Curie

Paris, , 75005

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