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

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Brief Title

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

Official Title

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
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response rate


Condition

Retinoblastoma

Intervention

Temozolomide

Study Arms / Comparison Groups

 temozolomide
Description:  

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

Drug

Estimated Enrollment

3

Start Date

March 2012

Completion Date

June 2015

Primary Completion Date

June 2015

Eligibility 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
      

Gender

All

Ages

N/A - 21 Years

Accepts Healthy Volunteers

No

Contacts

Sandra Luna-Fineman, , 

Location Countries

Guatemala

Location Countries

Guatemala

Administrative Informations


NCT ID

NCT01857752

Organization ID

PEDSEYE0003

Secondary IDs

22753

Responsible Party

Sponsor

Study Sponsor

Stanford University


Study Sponsor

Sandra Luna-Fineman, Principal Investigator, Stanford University


Verification Date

January 2017