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


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Retinoblastoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

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: Initial diagnosis (mass) At relapse (mass)

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Sandra Luna-Fineman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

PEDSEYE0003

NCT ID:

NCT01857752

Start Date:

June 2012

Completion Date:

June 2015

Related Keywords:

  • Retinoblastoma
  • Retinoblastoma
  • Retinoblastoma

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