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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01857752
First received: March 25, 2013
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

Primary Objectives:

  1. To investigate the 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:

    • A. Initial diagnosis (mass)
    • B. At relapse (mass)
  2. To determine hematologic toxicity: absolute neutrophil count (ANC), platelets and hemoglobin count.

Secondary Objectives:

  1. To determine the response in other metastatic sites (non target) (orbit, bone marrow, bone, lung, liver and others)
  2. To determine the remission rate and time to relapse on temozolomide.
  3. To document the response of leptomeningeal metastasis (cerebrospinal fluid) to temozolomide

Condition Intervention Phase
Retinoblastoma
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Response rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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)

  • Evaluate the toxicity suffered during each cycle of temozolamide will be evaluated using the CTCAE v3.0 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: April 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: temozolomide Drug: Temozolomide

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Metastasis to the CNS is defined as a mass in the chiasm or other site in the CNS, confirmed by MRI and/or

    CT:

    1. At diagnosis
    2. At relapse after conventional therapy.

    It is acceptable to have other sites of metastatic disease: lymphatic, bone, bone marrow or others.

  4. All sites of metastasis must be measured in 3 planes, in millimeters and described in POND (Pediatric Oncology Network Database*)
  5. Quality of life must be 3 by Lansky and 50% by Karnofksy
  6. Hemogram: Hemoglobin of 7, ANC of 750, platelets of 75K.
  7. 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.
  8. Treatment must start not more than 15 days from diagnosis of metastatic retinoblastoma.
  9. 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.
  10. 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.
  11. 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.

Exclusion Criteria:

  1. Patients with metastatic to CNS with only CSF involvement are NOT ELIGIBLE.
  2. 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.
  3. Diagnosis of AIDS or HIV positive.
  4. Patients with disease NOT in the CNS are NOT eligible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857752

Locations
Guatemala
Unidad Nacional de Oncologia Pediatrica Not yet recruiting
Guatemala, Guatemala
Contact: Mauricio Castellanos, MD    011-502-2328-9600    castellanoserick@hotmail.com   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sandra Luna-Fineman Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01857752     History of Changes
Other Study ID Numbers: PEDSEYE0003, 22753
Study First Received: March 25, 2013
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Retinoblastoma

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
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014