Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
1 other identifier
interventional
47
1 country
6
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 an effective medicine in killing cancer cells. Thalidomide works by blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. This research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors. This study will try to find out how well Thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 1999
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFebruary 5, 2019
February 1, 2019
7.3 years
September 12, 2005
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.
To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.
To determine the toxicity of this drug regimen.
Secondary Outcomes (2)
To determine whether the multi-agent chemotherapy regimen of thalidomide and carboplatin, in patients with recurrent brain stem gliomas will extend their survival as compared to historical controls.
To formulate experimentally derived hypothesis in order to establish a basis for future investigational studies.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Children's Hospitals and Clinics
Minneapolis, Minnesota, 55404, United States
Children's Hospitals and Clinics
Saint Paul, Minnesota, 55404, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Children's Medical Center
Dayton, Ohio, 45404, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stewart Goldman, MD
Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Head
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
December 1, 1999
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
February 5, 2019
Record last verified: 2019-02