Trials Sponsors Conditions Drugs Pricing

Conditions

Retinoblastoma Children Retinal Neoplasm

Outcome Measures

Primary Outcomes (1)

Rate of enucleation and external beam irradiation
From first day of treatment to 18 months after the end of treatments

Secondary Outcomes (6)

Number of relapses diagnosticated by fundus examination under general anesthesia until the age of 4 years, and without general anesthesia for older patients
5 years
Prospective evaluation of the systemic, ocular and general sides effects (short term) of the intravenous chemotherapy, intraarterial chemotherapy, combined to the local treatments as well as the intravitreal injections of Melphalan
5 years
Prospective evaluation of the systemic, ocular and general sides effects (medium and long term) of the intravenous chemotherapy, intraarterial chemotherapy, combined to the local treatments as well as the intravitreal injections of Melphalan
5 years
Response to intravitreal chemotherapy by Melphalan
18 months
Radiation doses received during intraarterial procedures
18 months
+1 more secondary outcomes

Study Arms (3)

(IV)Intravenous chemotherapy, laser diode

OTHER

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).

Drug: VP16, carboplatinDrug: Carboplatin + laser day 1 (chemothermotherapy)Device: Laser (local treatment)Device: cryoapplication (local treatment)Radiation: I125 radioactive plaques (local treatment)Drug: intravitreal Melphalan (local treatment)

(IA) Intraarterial Melphalan

OTHER

Interventions

VP16, carboplatinDrug

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

Also known as: etoposide, vepesid, chemotherapy

(IV)Intravenous chemotherapy, laser diode

MelphalanDrug

intraarterial injections, 3 to 6 cycles (1 month)

Also known as:

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
ETOPOSIDE TEVA 20 mg/ml, solution à diluer pour perfusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
INJECTION
View registry record
Formulated product
CARBOPLATINE TEVA 10 mg/ml, solution pour perfusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
INJECTION
View registry record
Formulated product
MELPHALAN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
ALKERAN 50 mg poudre et solvant pour solution pour perfusion Melphalan
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

ETOPOSIDE TEVA 20 mg/ml, solution à diluer pour perfusion
Named ingredient: Etoposide
View registry record
CARBOPLATINE TEVA 10 mg/ml, solution pour perfusion
Named ingredient: Carboplatin
View registry record
MELPHALAN
Named ingredient: Melphalan
View registry record
ALKERAN 50 mg poudre et solvant pour solution pour perfusion Melphalan
Named ingredient: Melphalan
View registry record

Eligibility Criteria

AgeUp to 6 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

Sponsors & Collaborators

Study Sites (1)

Institut Curie

Paris, 75005, France

MeSH Terms

Conditions

RetinoblastomaRetinal Neoplasms

Interventions

EtoposideCarboplatinDrug TherapyMelphalanVincristinePlatinum CompoundsLasersLasers, Semiconductor

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic Type

Study Officials

Isabelle Aerts, MD
Institut Curie - Paris - France
STUDY DIRECTOR
Catherine Devoldere, MD
Amiens (FR), University College Hospital
PRINCIPAL INVESTIGATOR
Isabelle Pellier, MD
Angers (FR), University College Hospital
PRINCIPAL INVESTIGATOR
Véronique Laithier, MD
Besançon (FR), Jean Minjoz Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 15, 2016

Study Start

February 2012

Actual (reported)

Primary Completion

January 2023

Actual (reported)

You may not qualify if:

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.
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.
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.
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.
+3 more criteria

Conservative Treatments of Retinoblastoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

(IV)Intravenous chemotherapy, laser diode

(IA) Intraarterial Melphalan

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

(IV-PM) Intravenous 3 drugs chemotherapy

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

(IV)Intravenous chemotherapy, laser diode

(IA) Intraarterial Melphalan

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

(IV-PM) Intravenous 3 drugs chemotherapy

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source records

Locations