Phase I Trial of Periocular Topotecan in Retinoblastoma

Learn more about:
Related Clinical Trial
Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Injection in the Treatment of Retinoblastoma RB Liquid Biopsy Biorepository Topotecan and Melphalan for Retinoblastoma Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure – Preliminary Study Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma. Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study Topotecan Episcleral Plaque for Treatment of Retinoblastoma G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment PCI Imaging System in Pediatric Ophthalmology Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients Conservative Treatments of Retinoblastoma Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma Photoscreening for Retinoblastoma RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients Studying Health Outcomes After Treatment in Patients With Retinoblastoma Chemotherapy Treatment for Children With Intraocular Germ-Line Retinoblastoma Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma Intra-arterial Chemotherapy for Retinoblastoma Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular Stage Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma Phase I Trial of Periocular Topotecan in Retinoblastoma Episcleral Topotecan for Treatment of Group D Retinoblastoma Can Pretreatment MRI be Used to Predict Intra-arterial Chemotherapy Response in Retinoblastoma? CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation Alternating Systemic Chemotherapy and Intra-Arterial Melphalan (IAM) Chemotherapy in Children With Intra-Ocular Retinoblastoma Chemotherapy in Treating Patients With Retinoblastoma New Strategies to Detect Cancers in Carriers of Mutations in RB1 Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma Carboplatin Plus Vincristine in Treating Children With Retinoblastoma Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma Quality of Life in Children Cured of Retinoblastoma Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009) Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma SPT Screening in Irradiated Hereditary Retinoblastoma Survivors Attention to Retinoblastoma Diagnosed in the Trauma Setting Carboplatin Periocular Injection for Retinoblastoma Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala Research on the Environment and Children’s Health: Retinoblastoma Intravitreal Injections of Melphalan for Retinoblastoma Efficacy Study of Lucentis in the Treatment of Retinoblastoma Feasibility of Generating Pluripotent Stem Cells From Patients With Familial Retinoblastoma A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma Retinoblastoma Survivor Study: Assessment of General Health and Quality of Life Retinoblastoma Biomarker Study Cancer Biology of Retinoblastoma Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma Intra-arterial Chemotherapy for Children With Retinoblastoma Molecular Analysis of Retinoblastoma

Brief Title

Phase I Trial of Periocular Topotecan in Retinoblastoma

Official Title

Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma

Brief Summary

      This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of
      periocular topotecan in patients with relapsed-resistant retinoblastoma.
    

Detailed Description

      Patients with bilateral retinoblastoma who have relapsed after attempts of conservative
      therapy with standard regimens such as carboplatin, etoposide, vincristine and external beam
      radiotherapy who face immediate enucleation of their single remaining eye are eligible for
      this protocol. Starting dose of topotecan will be 0.5 mg and dose escalation will be done by
      the accelerated titration method. Any Grade 3 ocular toxicity or grade 4 non ocular toxicity
      will be designed as the dose limiting toxicity. Grade 2 scleral toxicity will be considered
      for DLT. In case of grade 2 ocular toxicity or grade 3 systemic toxicity, the escalation dose
      will be 0.25 mg. Maximal dose will be 2 mg.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Dose limiting toxicity

Secondary Outcome

 Response rate, description of toxicity, pharmacokinetic profile

Condition

Retinoblastoma

Intervention

Topotecan


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

5

Start Date

March 2007

Completion Date

April 2008

Primary Completion Date

December 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Group Vb (Reese Ellsworth)

          -  Relapsed or progressed after carboplatin-based regimens and external beam radiotherapy

          -  Enucleation of the contralateral eye

          -  Normal renal and liver function

        Exclusion Criteria:

          -  Presence of glaucoma, rubeosis iridis, anterior chamber extension

          -  Extraocular disease

          -  Adequate follow up impossible for social reasons
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

Guillermo L Chantada, MD, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT00460876

Organization ID

14711603062



Study Sponsor

Hospital JP Garrahan


Study Sponsor

Guillermo L Chantada, MD, Principal Investigator, Hospital JP Garrahan


Verification Date

April 2008