Back to resultsThalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
Primary Purpose
Brain Stem Neoplasms, Primary, Neoplasms, Brain Stem
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Thalomid
External Beam Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Stem Neoplasms, Primary focused on measuring Brain stem glioma
Eligibility Criteria
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.
Sites / Locations
- Phoenix Children's Hospital
- Children's Memorial Hospital
- Children's Hospitals and Clinics
- Children's Hospitals and Clinics
- Washington University Medical Center
- Children's Medical Center
Outcomes
Primary Outcome Measures
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 Outcome Measures
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.
Full Information
NCT ID
NCT00179881
First Posted
September 12, 2005
Last Updated
February 1, 2019
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00179881
Brief Title
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
Official Title
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Stem Neoplasms, Primary, Neoplasms, Brain Stem
Keywords
Brain stem glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Thalomid
Intervention Type
Procedure
Intervention Name(s)
External Beam Radiation Therapy
Primary Outcome Measure Information:
Title
To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.
Title
To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.
Title
To determine the toxicity of this drug regimen.
Secondary Outcome Measure Information:
Title
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.
Title
To formulate experimentally derived hypothesis in order to establish a basis for future investigational studies.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stewart Goldman, MD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Children's Hospitals and Clinics
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Children's Hospitals and Clinics
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
We'll reach out to this number within 24 hrs