- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179881
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85016
- Phoenix Children's Hospital
-
-
Illinois
-
Chicago, Illinois, United States, 60614
- Children's Memorial Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics
-
Saint Paul, Minnesota, United States, 55404
- Children's Hospitals and Clinics
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University Medical Center
-
-
Ohio
-
Dayton, Ohio, United States, 45404
- Children's Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Infratentorial Neoplasms
- Neoplasms
- Glioma
- Brain Neoplasms
- Brain Stem Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Carboplatin
- Thalidomide
Other Study ID Numbers
- CNS 1099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Stem Neoplasms, Primary
-
Xinhua Hospital, Shanghai Jiao Tong University...UnknownChildhood Brain Stem NeoplasmChina
-
Zhejiang Cancer HospitalRecruiting
-
National Cancer Institute (NCI)CompletedUntreated Childhood Brain Stem GliomaUnited States
-
National Cancer Institute (NCI)CompletedUntreated Childhood Brain Stem GliomaUnited States
-
National Cancer Institute (NCI)CompletedUntreated Childhood Brain Stem GliomaUnited States
-
Paul Graham FisherNational Cancer Institute (NCI); National Institutes of Health (NIH)TerminatedBrain Cancer | Pontine Tumors | Brain Stem TumorsUnited States
-
National Cancer Institute (NCI)CompletedGlioblastoma | Gliosarcoma | Anaplastic Astrocytoma | Untreated Childhood Brain Stem Glioma | Giant Cell Glioblastoma | Untreated Childhood Anaplastic Astrocytoma | Untreated Childhood Giant Cell Glioblastoma | Untreated Childhood Glioblastoma | Untreated Childhood Gliosarcoma | Brain Stem Glioma | Untreated... and other conditionsUnited States
-
NewLink Genetics CorporationCompletedGlioma | Glioblastoma Multiforme | Gliosarcoma | Ependymoma | Medulloblastoma | Diffuse Intrinsic Pontine Glioma | Malignant Brain Tumor | Primary CNS TumorUnited States
-
Duke UniversityTerminated
-
ABM Therapeutics Shanghai Company LimitedRecruitingPrimary Malignant Brain TumorChina
Clinical Trials on Carboplatin
-
Eisai Inc.CompletedCancerUnited States, Austria, India
-
Samyang Biopharmaceuticals CorporationCompleted
-
NHS Greater Glasgow and ClydeCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited Kingdom, Australia, New Zealand
-
Duke UniversityCompletedBrain and Central Nervous System TumorsUnited States, Canada
-
National Cancer Institute (NCI)CompletedBreast Cancer | Ovarian CancerUnited States
-
National Cancer Institute (NCI)Children's Oncology GroupCompletedBrain and Central Nervous System TumorsUnited States, Canada, Puerto Rico, Australia, Netherlands, New Zealand, Switzerland
-
All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUnknownIntraocular RetinoblastomaIndia
-
MEI Pharma, Inc.CompletedPeritoneal Neoplasms | Ovarian Cancer | Fallopian Tube CancerUnited States, Spain, Belgium, United Kingdom, Australia, Italy, Poland
-
Medical Research CouncilEuropean Organisation for Research and Treatment of Cancer - EORTCCompletedTesticular Germ Cell TumorUnited Kingdom, Canada, Norway, Netherlands, South Africa, Brazil, Finland
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States