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

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ClinicalTrials.gov Identifier: NCT01857752
Recruitment Status : Terminated (accrual)
First Posted : May 20, 2013
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE March 25, 2013
First Posted Date  ICMJE May 20, 2013
Last Update Posted Date January 30, 2017
Actual Study Start Date  ICMJE March 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
  • Response rate [ Time Frame: 8 weeks ]
    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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala
Official Title  ICMJE Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala
Brief Summary

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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retinoblastoma
Intervention  ICMJE Drug: Temozolomide
Study Arms  ICMJE Experimental: temozolomide
Intervention: Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 26, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2013)
16
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guatemala
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01857752
Other Study ID Numbers  ICMJE PEDSEYE0003
22753 ( Other Identifier: Stanford IRB )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandra Luna-Fineman Stanford University
PRS Account Stanford University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP