Status:
COMPLETED
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Brain Stem Neoplasms, Primary
Neoplasms, Brain Stem
Eligibility:
All Genders
3-21 years
Phase:
PHASE2
Brief Summary
Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients must be \>/= 3 and \</= 21 years of age.
- 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: \</= 0.7 mg/dl (age 3-10yrs.), \</= 1.0 mg/dl (11-12yrs.). and \</= 1.2 (13-21yrs.).
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00179881
Start Date
December 1 1999
End Date
April 1 2007
Last Update
February 5 2019
Active Locations (6)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
3
Children's Hospitals and Clinics
Minneapolis, Minnesota, United States, 55404
4
Children's Hospitals and Clinics
Saint Paul, Minnesota, United States, 55404