Chemotherapy in Treating Patients With 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

Chemotherapy in Treating Patients With Retinoblastoma

Official Title

A TRIAL OF ADJUVANT CHEMOTHERAPY IN PATIENTS WITH INTRAOCULAR RETINOBLASTOMA

Brief Summary

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
      patients with retinoblastoma.
    

Detailed Description

      OBJECTIVES: I. Estimate the response rate to adjuvant carboplatin (CBDCA) alone in children
      with intraocular retinoblastoma. II. Assess the overall survival, disease-free survival, and
      time to treatment failure in these patients. III. Attempt to maintain a 90% disease-free
      survival rate with this treatment. IV. Estimate the percentage of disease-free survivors who
      do not require the use of radiotherapy after adjuvant CBDCA. V. Assess the toxicity of this
      treatment. VI. Estimate the percentage of functional eyes salvaged using this
      radiation-sparing protocol and compare these results, in a nonrandomized manner, with
      historical treatment results in this population.

      OUTLINE: Patients are stratified according to vitreous disease (yes vs no). Patients receive
      carboplatin IV over 1 hour on day 0. Treatment repeats every 2-3 weeks for 2 courses.
      Patients achieving complete response (CR) proceed to local control measures consisting of
      cryotherapy, laser photocoagulation, etc. (except brachytherapy). Patients not achieving CR
      continue with carboplatin until local control measures feasible. Patients with vitreous
      disease achieving CR receive 2 additional courses and then receive local control measures.
      Patients with vitreous disease not achieving CR receive intensive chemotherapy. Patients
      receive intensive chemotherapy consisting of vincristine IV on days 0, 7, and 14, cisplatin
      IV over 6 hours on day 0, etoposide IV on days 1 and 2, followed by cyclophosphamide IV over
      60 minutes on days 1 and 2. Patients receive filgrastim (G-CSF) subcutaneously beginning on
      day 3 and until blood counts recover. Treatment repeats every 2-4 weeks for 2 courses beyond
      CR. Patients are followed for 3 years.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-6 years.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Retinoblastoma

Intervention

filgrastim


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

Biological

Estimated Enrollment

50

Start Date

May 1995

Completion Date

January 2001

Primary Completion Date

January 2001

Eligibility Criteria

        DISEASE CHARACTERISTICS: Intraocular retinoblastoma Ophthalmologic exam under anesthesia
        within 3 weeks prior to registration No pathologic confirmation required No evidence of
        extraocular disease, i.e.: Negative head MRI or CT (contrast not required) Negative CSF
        cytology Negative bone marrow aspiration and biopsy

        PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Hematopoietic: Not
        specified Hepatic: Bilirubin less than 2.0 mg/dl SGOT or SGPT less than 5 times upper limit
        of normal Renal: Creatinine normal for age OR Creatinine clearance greater than 50 ml/min

        PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
      

Gender

All

Ages

N/A - 17 Years

Accepts Healthy Volunteers

No

Contacts

Ira Dunkel, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00002675

Organization ID

95-040

Secondary IDs

CDR0000064317


Study Sponsor

Memorial Sloan Kettering Cancer Center


Study Sponsor

Ira Dunkel, MD, Study Chair, Memorial Sloan Kettering Cancer Center


Verification Date

June 2013