Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala

NCT01857752 | Terminated Phase 2

• 2 other identifiers: PEDSEYE000322753
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• A. Initial diagnosis (mass)
• B. At relapse (mass)
• To determine hematologic toxicity: absolute neutrophil count (ANC), platelets and hemoglobin count.
• To determine the response in other metastatic sites (non target) (orbit, bone marrow, bone, lung, liver and others)
• To determine the remission rate and time to relapse on temozolomide.
• To document the response of leptomeningeal metastasis (cerebrospinal fluid) to temozolomide

Conditions

Retinoblastoma

Keywords

Retinoblastoma

Outcome Measures

Primary Outcomes (2)

• Response rate

  Response rate (complete response plus partial response) of temozolomide for 8 weeks (2 cycles), in patients with retinoblastoma metastatic to the central nervous system (mass only) in two strata: 1. Initial diagnosis (mass) 2. At relapse (mass)

  8 weeks

• Evaluate the toxicity suffered during each cycle of temozolamide will be evaluated using the CTCAE v3.0

  8 weeks

Study Arms (1)

temozolomide

EXPERIMENTAL

Drug: Temozolomide

Interventions

Temozolomide DRUG

temozolomide

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• This study must be evaluated and confirmed by the local ethics committees and institutional review board of the participating institution, in accordance to the declaration of Helsinki. Informed consent must be administered and the parent or guardian must sign the document, authorized by the Ethics Committee and human subjects (therapy can not start if the documents are not signed).
• Patients less than 21 years of age with diagnosis of retinoblastoma with metastasis to the CNS (central nervous system) must be confirmed by an ophthalmologist and/or a pathologist; in conjunction with the pediatric oncologist.
• Metastasis to the CNS is defined as a mass in the chiasm or other site in the CNS, confirmed by MRI and/or
• CT:
• At diagnosis
• At relapse after conventional therapy.
• It is acceptable to have other sites of metastatic disease: lymphatic, bone, bone marrow or others.
• All sites of metastasis must be measured in 3 planes, in millimeters and described in POND (Pediatric Oncology Network Database\*)
• Quality of life must be 3 by Lansky and 50% by Karnofksy
• Hemogram: Hemoglobin of 7, ANC of 750, platelets of 75K.
• Chemistry: direct bilirubin less than 3.0, indirect bilirubin less than 4.0, AST less 5x normal and ALT 5x normal, creatinine less than 1.5.
• Treatment must start not more than 15 days from diagnosis of metastatic retinoblastoma.
• Every patient with relapse or progression into the CNS must be documented with CT scan or MRI of the brain. Other sites of relapse may be evaluated, including bone marrow.
• Patients who are newly diagnosed should have not received any other chemotherapeutic therapy (with the exception of dexamethasone) 1 week before starting, or radiotherapy, 4 weeks before starting.
• All patients to be included in this study must be presented to the principal investigator using Horizon Live Web-conferencing through the Cure4Kids website. Eligibility and target CNS sites will be determined, as well as non-target sites.

You may not qualify if:

• Patients with metastatic to CNS with only CSF involvement are NOT ELIGIBLE.
• Relapse patients should have NOT received chemotherapy for 4 weeks, and no patient should have received nitroureas (melphalan, CCNU or mustard). No patient should have received radiation therapy in the previous 42 days. These patients are NOT eligible.
• Diagnosis of AIDS or HIV positive.
• Patients with disease NOT in the CNS are NOT eligible

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Unidad Nacional de Oncologia Pediatrica

Guatemala City, Guatemala

Location

MeSH Terms

Conditions

Retinoblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

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, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sandra Luna-Fineman

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: May 20, 2013
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

GU (1)