<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04455139</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01967</org_study_id>
    <nct_id>NCT04455139</nct_id>
  </id_info>
  <brief_title>A Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma</brief_title>
  <acronym>EuRbG2018</acronym>
  <official_title>A Phase II Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma, With Randomization Depending on the Site of Relapse or on Previous Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Beck Popovic Maja</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      While 95% of patients with retinoblastoma can be cured nowadays, treatment of relapse remains&#xD;
      challenging, ending often in enucleation and/or radiotherapy. In the last 10 years, new&#xD;
      treatment modalities have been developed to give the chance of cure also in relapse, avoiding&#xD;
      enucleation which results in esthetic sequelae and orbital growth problems, and radiotherapy&#xD;
      which significantly increases the risk of secondary cancers in hereditary retinoblastoma. The&#xD;
      current protocol aims at covering all types of relapses in retinoblastoma, with treatments&#xD;
      adapted to the site of relapse, at harmonizing the new eye- and vision-preserving treatment&#xD;
      procedures, and evaluating their efficacy and toxicity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims at improving treatment of patients with recurrent Rb through a specific&#xD;
      approach according to the site of relapse and a uniform and well-defined treatment schedule.&#xD;
      A precise observation of early, intermediate and long-term toxic effects with treatment&#xD;
      recommendation will be done. For intravitreal relapse, the trial will focus on a&#xD;
      randomization between melphalan (standard) and topotecan (investigational). For retinal /&#xD;
      diffuse subretinal relapse in patients not having received prior IAC, it will focus on a&#xD;
      randomization between IAC melphalan only and IAC combining melphalan+topotecan. For vitreous&#xD;
      and retinal relapse the treatment will be a sequential administration of intravitreous and&#xD;
      intraarterial injections (observational patients).&#xD;
&#xD;
      The duration of patient recruitment is 3 years, the duration of patient follow-up for study&#xD;
      purposes is until at least 2 years after end of current relapse treatment. A long-term&#xD;
      follow-up of at least 10 years on a regular basis will be proposed at the end of the study,&#xD;
      with the aim to record the occurrence of secondary malignancies, metastases and long term&#xD;
      sequelae.&#xD;
&#xD;
      The overall objective is to provide a conservative eye-preserving treatment for pediatric&#xD;
      patients with Rb who have failed prior standard treatments and have no other option than&#xD;
      enucleation and/or EBR, to preserve functional vision and to limit general and ocular&#xD;
      toxicity.&#xD;
&#xD;
      Primary objectives&#xD;
&#xD;
      A. To reduce the incidence of retinal toxicity in IVitC treatment while retaining similar&#xD;
      efficacy of tumor control, in vitreous relapse.&#xD;
&#xD;
      B. To reduce further relapse by IAC with melphalan+topotecan compared to IAC with melphalan&#xD;
      only in patients not having received prior IAC and presenting retinal / diffuse subretinal&#xD;
      relapse.&#xD;
&#xD;
      The primary outcome, on which the sample size calculation is based, is the rate of retinal&#xD;
      toxicity following IVitC treatment with melphalan as compared to topotecan. Currently a&#xD;
      retinal toxicity rate of 40% is reported with melphalan. Topotecan is reportedly less toxic&#xD;
      and the investigators expect a retinal toxicity of 10% or less. To have 90% power of&#xD;
      detecting a reduction of 30% in retinal toxicity at the 5% level of significance, 43 patients&#xD;
      are required in each arm. Allowing for a 5% drop out rate per year for 3 years, the&#xD;
      investigators estimate that 50 patients are required in each of arm of this study. Concerning&#xD;
      the second primary objective the investigators postulate that the eye salvage rate can be&#xD;
      increased by adding topotecan to melphalan from overall 67% to 84% at 2 years. A randomized&#xD;
      2:1 (arm with association Topotecan-Melphalan and arm with Melphalan only, respectively) non&#xD;
      comparative phase II will be performed. In the Topotecan and Melphalan arm, 67% (p0) or less&#xD;
      of eye salvage rate is considered as ineffective, 84% (p1) as active. 64 patients will be&#xD;
      included in the Topotecan and Melphalan arm, with a type one error of 7% and a type two error&#xD;
      of 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 15, 2021</start_date>
  <completion_date type="Anticipated">March 15, 2027</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2027</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of retinal toxicity of intravitreous administration of melphalan versus topotecan assessed by CTCAE v5.0</measure>
    <time_frame>at 1 month after treatment completion</time_frame>
    <description>parameters: salt and pepper retinopathy, choroidopathy, number of injections until toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relapse rate after IAC by melphalan only and IAC by melphalan + topotecan</measure>
    <time_frame>at 2 years of follow-up</time_frame>
    <description>parameter: eye retention rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of intravitreous topotecan compared to intravitreous melphalan (number of injections to tumor clearance in vitreous)</measure>
    <time_frame>at 3 or 6 months after last intravitreous injection</time_frame>
    <description>Parameter: number of injections to tumor clearance in vitreous</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular survival (eye salvage rate)</measure>
    <time_frame>at 2 years since study entry</time_frame>
    <description>parameters: enucleation and EBR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with ocular (non retinal) and systemic toxicity assessed by CTCAE v5.0</measure>
    <time_frame>Weekly (IVitC) or monthly (IAC) during treatment, at end of treatment (1 month after last injection), at 6, 12 and 24 months, yearly until 60 months</time_frame>
    <description>parameter: number of participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of vision assessed by visual acuity</measure>
    <time_frame>at 5 years of age</time_frame>
    <description>parameters: Logmar values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of early (within 1 month), intermediate (2-12 months) and late (&gt; 12 months) ocular and systemic general adverse events during regular ophthalmological and clinical examinationassessed by CTCAE v5.0</measure>
    <time_frame>Weekly (IVitC) or monthly (IAC) during treatment, at end of treatment (1 month after last injection), at 6, 12 and 24 months, yearly until 60 months</time_frame>
    <description>parameter: incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of the cumulative radiation exposure during the IAC procedures by routinely used devices (sub-study limited to Lausanne) by B three thermoluminescent dosimeters</measure>
    <time_frame>at 1 month after the last IAC</time_frame>
    <description>parameter: B three thermoluminescent dosimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of the occurrence of secondary malignancies and/or metastases and long term sequelae</measure>
    <time_frame>during a follow-up of at least 10 years</time_frame>
    <description>parameter: incidence</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">196</enrollment>
  <condition>Eye Cancer, Retinoblastoma</condition>
  <arm_group>
    <arm_group_label>Treatment 1a</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IVitC melphalan (randomized) in case of vitreous relapse only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 1b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IVitC topotecan (randomized) in case of vitreous relapse only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 2a</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IAC melphalan (randomized) in case of retinal/diffuse subretinal relapse with no prior intra-arterial treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 2b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IAC melphalan and topotecan (randomized) in case of retinal/diffuse subretinal relapse with no prior intra-arterial treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 2c</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>IAC melphalan and topotecan (randomized) in case of retinal/diffuse subretinal relapse with prior intra-arterial treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 3a</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>sequential administration of IVitC melphalan and IAC melphalan in case of combined vitreous and retinal/diffuse subretinal relapse, if no pretreatment with intra-arterial treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 3b</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>sequential administration of IVitC melphalan and IAC melphalan and topotecan, in case of combined vitreous and retinal/diffuse subretinal relapse, if prior pretreatment with intra-arterial treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topotecan</intervention_name>
    <description>intravitreal or intra-arterial administration of topotecan</description>
    <arm_group_label>Treatment 1b</arm_group_label>
    <arm_group_label>Treatment 2b</arm_group_label>
    <other_name>hycamtin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
    <description>intravitreal or intra-arterial administration of topotecan</description>
    <arm_group_label>Treatment 1a</arm_group_label>
    <arm_group_label>Treatment 2a</arm_group_label>
    <arm_group_label>Treatment 2b</arm_group_label>
    <other_name>alkeran</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Eye with recurrent Rb clinically defined as one or the combination of the following:&#xD;
&#xD;
               -  vitreous recurrence only&#xD;
&#xD;
               -  retinal / diffuse subretinal relapse only not amenable to focal treatment such as&#xD;
                  thermotherapy, cryotherapy or plaque&#xD;
&#xD;
               -  combined vitreous and retinal/diffuse subretinal relapse&#xD;
&#xD;
          2. Minimally required interval between study entry and time of the last treatment: 2&#xD;
             months (with a monthly follow-up), except for small retinal / subretinal tumors&#xD;
             treated focally, not related to the current relapse&#xD;
&#xD;
          3. Photographic documentation of fundus at study entry&#xD;
&#xD;
          4. Registration into the study and start of treatment must occur no later than 14 days&#xD;
             after diagnosis of recurrence&#xD;
&#xD;
          5. Mandatory ultrasound biomicroscopy (UBM) at 35 or 50 MHz in case of opaque media or&#xD;
             insufficient pupillary dilatation for evaluation of the posterior chamber / pars plana&#xD;
&#xD;
          6. Age ≥3 months and &lt; 11 years (10.99)&#xD;
&#xD;
          7. Weight ≥5 kg (in case of IAC eligibility or sequential IVitC/IAC eligibility)&#xD;
&#xD;
          8. Possibility of follow-up until at least 2 years after end of current relapse treatment&#xD;
&#xD;
          9. Written informed consent by parents or legal representative before enrolment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Relapse with any uveal involvement and/or anterior chamber involvement&#xD;
&#xD;
          2. Indication for another treatment option according to investigator's judgement&#xD;
&#xD;
          3. Clinical/MRI signs of extraocular disease, including metastatic disease&#xD;
&#xD;
          4. Inadequate organ function (in case of IAC or sequential IVitC / IAC eligibility):&#xD;
&#xD;
               -  absolute neutrophils count &lt;0.5 G/l&#xD;
&#xD;
               -  thrombocytes count &lt;100 G/l&#xD;
&#xD;
               -  creatinine above normal value for age&#xD;
&#xD;
               -  ALAT more than 2x above upper normal limit&#xD;
&#xD;
               -  bilirubin above upper normal limit&#xD;
&#xD;
          5. Other (simultaneous) malignancies&#xD;
&#xD;
          6. Contraindication or known hypersensitivity to study drugs&#xD;
&#xD;
          7. Severe concomitant diseases (e.g. immune deficiency syndrome)&#xD;
&#xD;
          8. Current or recent (within 30 days prior to date of written informed consent) treatment&#xD;
             with another investigational drug or participation in another interventional clinical&#xD;
             trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maja Beck Popovic, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Lausanne University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maja Beck Popovic, Prof</last_name>
    <phone>213143567</phone>
    <phone_ext>+41</phone_ext>
    <email>maja.beck-popovic@chuv.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie-Louise Choucair, MD</last_name>
    <phone>213142005</phone>
    <phone_ext>+41</phone_ext>
    <email>marie-louise.choucair@chuv.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHUV Lausanne University Hospital</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maja Beck Popovic, MD</last_name>
      <phone>+41213143567</phone>
      <email>maja-beck.popovic@chuv.ch</email>
    </contact>
    <investigator>
      <last_name>Maja Beck Popovic, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie-Louise Choucair, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christina Stathopoulos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francis Munier, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>April 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>November 18, 2021</last_update_submitted>
  <last_update_submitted_qc>November 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Prof. Beck Popovic Maja</investigator_full_name>
    <investigator_title>Head of pediatric hematology oncology unit</investigator_title>
  </responsible_party>
  <keyword>relapsed retinoblastoma</keyword>
  <keyword>relapse of retinoblastoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinoblastoma</mesh_term>
    <mesh_term>Eye Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melphalan</mesh_term>
    <mesh_term>Topotecan</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04455139
org study id: 2018-01967
nct id: NCT04455139
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
While 95% of patients with retinoblastoma can be cured nowadays, treatment of relapse remains
      challenging, ending often in enucleation and/or radiotherapy. In the last 10 years, new
      treatment modalities have been developed to give the chance of cure also in relapse, avoiding
      enucleation which results in esthetic sequelae and orbital growth problems, and radiotherapy
      which significantly increases the risk of secondary cancers in hereditary retinoblastoma. The
      current protocol aims at covering all types of relapses in retinoblastoma, with treatments
      adapted to the site of relapse, at harmonizing the new eye- and vision-preserving treatment
      procedures, and evaluating their efficacy and toxicity.
The study aims at improving treatment of patients with recurrent Rb through a specific
      approach according to the site of relapse and a uniform and well-defined treatment schedule.
      A precise observation of early, intermediate and long-term toxic effects with treatment
      recommendation will be done. For intravitreal relapse, the trial will focus on a
      randomization between melphalan (standard) and topotecan (investigational). For retinal /
      diffuse subretinal relapse in patients not having received prior IAC, it will focus on a
      randomization between IAC melphalan only and IAC combining melphalan+topotecan. For vitreous
      and retinal relapse the treatment will be a sequential administration of intravitreous and
      intraarterial injections (observational patients).

      The duration of patient recruitment is 3 years, the duration of patient follow-up for study
      purposes is until at least 2 years after end of current relapse treatment. A long-term
      follow-up of at least 10 years on a regular basis will be proposed at the end of the study,
      with the aim to record the occurrence of secondary malignancies, metastases and long term
      sequelae.

      The overall objective is to provide a conservative eye-preserving treatment for pediatric
      patients with Rb who have failed prior standard treatments and have no other option than
      enucleation and/or EBR, to preserve functional vision and to limit general and ocular
      toxicity.

      Primary objectives

      A. To reduce the incidence of retinal toxicity in IVitC treatment while retaining similar
      efficacy of tumor control, in vitreous relapse.

      B. To reduce further relapse by IAC with melphalan+topotecan compared to IAC with melphalan
      only in patients not having received prior IAC and presenting retinal / diffuse subretinal
      relapse.

      The primary outcome, on which the sample size calculation is based, is the rate of retinal
      toxicity following IVitC treatment with melphalan as compared to topotecan. Currently a
      retinal toxicity rate of 40% is reported with melphalan. Topotecan is reportedly less toxic
      and the investigators expect a retinal toxicity of 10% or less. To have 90% power of
      detecting a reduction of 30% in retinal toxicity at the 5% level of significance, 43 patients
      are required in each arm. Allowing for a 5% drop out rate per year for 3 years, the
      investigators estimate that 50 patients are required in each of arm of this study. Concerning
      the second primary objective the investigators postulate that the eye salvage rate can be
      increased by adding topotecan to melphalan from overall 67% to 84% at 2 years. A randomized
      2:1 (arm with association Topotecan-Melphalan and arm with Melphalan only, respectively) non
      comparative phase II will be performed. In the Topotecan and Melphalan arm, 67% (p0) or less
      of eye salvage rate is considered as ineffective, 84% (p1) as active. 64 patients will be
      included in the Topotecan and Melphalan arm, with a type one error of 7% and a type two error
      of 5%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of retinal toxicity of intravitreous administration of melphalan versus topotecan assessed by CTCAE v5.0
time frame: at 1 month after treatment completion
description: parameters: salt and pepper retinopathy, choroidopathy, number of injections until toxicity
measure: Relapse rate after IAC by melphalan only and IAC by melphalan + topotecan
time frame: at 2 years of follow-up
description: parameter: eye retention rate
measure: Efficacy of intravitreous topotecan compared to intravitreous melphalan (number of injections to tumor clearance in vitreous)
time frame: at 3 or 6 months after last intravitreous injection
description: Parameter: number of injections to tumor clearance in vitreous
measure: Ocular survival (eye salvage rate)
time frame: at 2 years since study entry
description: parameters: enucleation and EBR
measure: Number of participants with ocular (non retinal) and systemic toxicity assessed by CTCAE v5.0
time frame: Weekly (IVitC) or monthly (IAC) during treatment, at end of treatment (1 month after last injection), at 6, 12 and 24 months, yearly until 60 months
description: parameter: number of participants
measure: Quality of vision assessed by visual acuity
time frame: at 5 years of age
description: parameters: Logmar values
measure: Incidence of early (within 1 month), intermediate (2-12 months) and late (> 12 months) ocular and systemic general adverse events during regular ophthalmological and clinical examinationassessed by CTCAE v5.0
time frame: Weekly (IVitC) or monthly (IAC) during treatment, at end of treatment (1 month after last injection), at 6, 12 and 24 months, yearly until 60 months
description: parameter: incidence
measure: Quantification of the cumulative radiation exposure during the IAC procedures by routinely used devices (sub-study limited to Lausanne) by B three thermoluminescent dosimeters
time frame: at 1 month after the last IAC
description: parameter: B three thermoluminescent dosimeters
measure: Incidence of the occurrence of secondary malignancies and/or metastases and long term sequelae
time frame: during a follow-up of at least 10 years
description: parameter: incidence
arm group label: Treatment 1a
arm group type: Active Comparator
description: IVitC melphalan (randomized) in case of vitreous relapse only
arm group label: Treatment 1b
arm group type: Experimental
description: IVitC topotecan (randomized) in case of vitreous relapse only
arm group label: Treatment 2a
arm group type: Active Comparator
description: IAC melphalan (randomized) in case of retinal/diffuse subretinal relapse with no prior intra-arterial treatment
arm group label: Treatment 2b
arm group type: Experimental
description: IAC melphalan and topotecan (randomized) in case of retinal/diffuse subretinal relapse with no prior intra-arterial treatment
arm group label: Treatment 2c
arm group type: No Intervention
description: IAC melphalan and topotecan (randomized) in case of retinal/diffuse subretinal relapse with prior intra-arterial treatment
arm group label: Treatment 3a
arm group type: No Intervention
description: sequential administration of IVitC melphalan and IAC melphalan in case of combined vitreous and retinal/diffuse subretinal relapse, if no pretreatment with intra-arterial treatment
arm group label: Treatment 3b
arm group type: No Intervention
description: sequential administration of IVitC melphalan and IAC melphalan and topotecan, in case of combined vitreous and retinal/diffuse subretinal relapse, if prior pretreatment with intra-arterial treatment
intervention type: Drug
intervention name: Topotecan
description: intravitreal or intra-arterial administration of topotecan
arm group label: Treatment 1b
arm group label: Treatment 2b
other name: hycamtin
intervention type: Drug
intervention name: Melphalan
description: intravitreal or intra-arterial administration of topotecan
arm group label: Treatment 1a
arm group label: Treatment 2a
arm group label: Treatment 2b
other name: alkeran
criteria: 
gender: All
minimum age: 3 Months
maximum age: 11 Years
healthy volunteers: No
last name: Maja Beck Popovic, Prof
role: Study Director
affiliation: Lausanne University Hospital
last name: Maja Beck Popovic, Prof
phone: 213143567
phone ext: +41
email: maja.beck-popovic@chuv.ch
last name: Marie-Louise Choucair, MD
phone: 213142005
phone ext: +41
email: marie-louise.choucair@chuv.ch
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Prof. Beck Popovic Maja
investigator title: Head of pediatric hematology oncology unit
mesh term: Retinoblastoma
mesh term: Eye Neoplasms
mesh term: Melphalan
mesh term: Topotecan