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Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma


Phase 2
3 Years
21 Years
Not Enrolling
Both
Brain Stem Neoplasms, Primary, Neoplasms, Brain Stem

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Trial Information

Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma


Inclusion Criteria:



- Patients must be >/= 3 and
- Patients must have a newly diagnosed or progressive brain stem tumor.

- If biopsy has been performed, patients with both high and low grade astrocytomas are
eligible.

- Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic
confirmation of brain stem glioma is mandatory for study entry.

- Cervicomedullary junction tumors are ineligible.

- Patients with a diagnosis of NF-1 are ineligible.

- Patients must be registered within 6 weeks from diagnosis or recurrence.

- Patients must have life expectancy > 6 weeks.

- Patients must have adequate hematologic and renal function: ANC >1,000/ul,
platelets>100,000/ul and creatinine normal for age: 1.0 mg/dl (11-12yrs.). and
- Written informed consent must be obtained according to institutional guidelines.

- Pregnant or nursing women are ineligible.

- Patients must be registered within 3 days prior to the start of protocol treatment.
Patients must not start treatment until informed consent is given and the patient is
registered. Willingness and ability to comply with the FDA-mandated S.T.E.P.S.®
program.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.

Principal Investigator

Stewart Goldman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago

Authority:

United States: Institutional Review Board

Study ID:

CNS 1099

NCT ID:

NCT00179881

Start Date:

December 1999

Completion Date:

April 2007

Related Keywords:

  • Brain Stem Neoplasms, Primary
  • Neoplasms, Brain Stem
  • Brain stem glioma
  • Brain Neoplasms
  • Neoplasms
  • Glioma
  • Brain Stem Neoplasms

Name

Location

Washington University Medical CenterSaint Louis, Missouri  63105
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Children's Memorial HospitalChicago, Illinois  60614
Children's Hospitals and ClinicsMinneapolis, Minnesota  55404
Children's Medical CenterDayton, Ohio  45404