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Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma (RbGALOP2)

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ClinicalTrials.gov Identifier: NCT03475121
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborators:
Hospital San Juan de Dios, Santiago
Hospital Pereyra Rossell, Montevideo
National Cancer Institute Rio de Janeiro
Hospital Sant Joan de Deu
Information provided by (Responsible Party):
Guillermo Chantada, Hospital JP Garrahan

Brief Summary:
This protocol provides guidelines for the management of non-metastatic unilateral retinoblastoma and introduces an innovative adjuvant therapy for higher risk patients based upon the results of the Grupo de America Latina de Oncologia Pediatrica (GALOP) I study. Conservative therapy will be not protocolized.

Condition or disease Intervention/treatment Phase
Unilateral Retinoblastoma Combination Product: Combination Chemotherapy plus Intrathecal Topotecan Combination Product: Higher Dose Combination Chemotherapy plus Intrathecal Topotecan Combination Product: Higher Dose Combination Chemotherapy plus Intrathecal Topotecan and Orbital Radiotherapy Other: No Adjuvant Therapy Phase 3

Detailed Description:
Patients with non-metastatic retinoblastoma undergoing enucleation will be staged using the American Joint Committee on Cancer (AJCC), version 8, Tumor, Node, Metastasis (TNM)- H system and the International Retinoblastoma Staging System (IRSS). IRSS stage I patients recognized as higher risk will be assigned for adjuvant therapy. Those with standard risk will not receive adjuvant therapy after enucleation. Higher risk patients are defined as those with pathological retrolaminar optic nerve invasion and-or any degree of scleral invasion (pT3b, pT3c, pT3d). Based on the results of the GALOP I protocol, they will receive a reduced dose adjuvant chemotherapy regimen with 3 cycles of alternating cyclophosphamide, vincristine and idarubicin alternating with another 3 cycles of carboplatin and etoposide. Six doses of intrathecal topotecan will be given. Patients presenting with severe buphthalmia (cT3c-cT3e) will receive neo-adjuvant therapy with the same intensive regimen but including a higher dose of carboplatin as per GALOP I protocol plus intrathecal topotecan and secondary enucleation followed by adjuvant chemotherapy for a total of 8 cycles. Stage II patients (pT4) will receive the same adjuvant regimen plus orbital radiotherapy (45 cGy).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GALOP II Protocol for the Treatment of Unilateral Retinoblastoma
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Topotecan

Arm Intervention/treatment
Experimental: Low Risk Patients
Patients with IRSS stage I, pT1, pT2 and pT3 stage will not receive adjuvant therapy
Other: No Adjuvant Therapy
Patients will not receive any adjuvant therapy after enucleation of the affected eye.

Experimental: Higher Risk Patients
Patients with IRSS stage I, pT3b, pT3c, pT3d will receive 6 cycles of adjuvant chemotherapy plus 6 doses of intrathecal topotecan
Combination Product: Combination Chemotherapy plus Intrathecal Topotecan
Adjuvant chemotherapy with a reduced dose (compared to GALOP I protocol) of carboplatin

Experimental: Stage II Patients
Patients with Stage II (pT4) will receive 6 cycles of adjuvant chemotherapy plus 6 doses of intrathecal topotecan and orbital radiotherapy
Combination Product: Higher Dose Combination Chemotherapy plus Intrathecal Topotecan and Orbital Radiotherapy
GALOP I-based systemic adjuvant therapy plus intrathecal topotecan and orbital radiotherapy (45 Gy) up to chiasm

Experimental: Patients with buphthalmus
Patients with buphthalmus (cT3c, cT3e) will receive 2 cycles of neo-adjuvant chemotherapy plus 6 doses of intrathecal topotecan followed by secondary enucleation and 6 cycles of adjuvant chemotherapy.
Combination Product: Higher Dose Combination Chemotherapy plus Intrathecal Topotecan
GALOP I-based systemic adjuvant therapy plus intrathecal topotecan




Primary Outcome Measures :
  1. Rate of extraocular relapses [ Time Frame: 3 years ]
    Number of participants experiencing extraocular relapse

  2. Evaluation of number of patients experiencing acute, chronic and fatal toxicities [ Time Frame: 5 years ]
    Number of participants experiencing treatment-related adverse effects and mortality as measured by CTCAE v4.0



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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of retinoblastoma confirmed at participating institutions
  • Ophthalmological diagnosis of unilateral retinoblastoma in patients undergoing conservative therapy.
  • No prior therapy for retinoblastoma
  • Lansky Performance Scale greater or equal to 50
  • Normal organ function in those patients assigned for chemotherapy
  • Signed informed consent

Exclusion Criteria:

  • Patients with unilateral retinoblastoma and germline mutations of the Rb1 gene or family history for retinoblastoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475121


Contacts
Contact: Guillermo L Chantada, MD, PhD 5411-4122-6000 gchantada@yahoo.com
Contact: Claudia Sampor 5411-4122-6000 claudiasampor@hotmail.com

Locations
Argentina
Hospital JP Garrahan Recruiting
Buenos Aires, CF, Argentina, C1245AAL
Contact: Carolina Cernadas, MD    541141226335    coordinacioninvestigacion@garrahan.gov.ar   
Contact: Guillermo Chantada, MD, PhD    541141226000    gchantada@yahoo.com   
Principal Investigator: Claudia Sampor, MD         
Sponsors and Collaborators
Hospital JP Garrahan
Hospital San Juan de Dios, Santiago
Hospital Pereyra Rossell, Montevideo
National Cancer Institute Rio de Janeiro
Hospital Sant Joan de Deu

Responsible Party: Guillermo Chantada, Staff Physician, Hospital JP Garrahan
ClinicalTrials.gov Identifier: NCT03475121     History of Changes
Other Study ID Numbers: 1031. Retinoblastoma GALOP 2
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents