Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma - Full Text View

Sponsored by:	Children's Memorial Hospital
Information provided by:	Children's Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00179881

Purpose

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.

Condition	Intervention	Phase
Brain Stem Neoplasms, Primary Neoplasms, Brain Stem	Drug: Carboplatin Drug: Thalomid Procedure: External Beam Radiation Therapy	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Thalidomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Further study details as provided by Children's Memorial Hospital:

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.

Estimated Enrollment:	47
Study Start Date:	December 1999

Eligibility

Ages Eligible for Study:	3 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179881

Locations

United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Minnesota
Children's Hospitals and Clinics
Saint Paul, Minnesota, United States, 55404
Children's Hospitals and Clinics
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Ohio
Children's Medical Center
Dayton, Ohio, United States, 45404

Sponsors and Collaborators

Children's Memorial Hospital

Investigators

Principal Investigator:

Stewart Goldman, MD

Children's Memorial Hospital

More Information

Study ID Numbers:	CNS 1099
Study First Received:	September 12, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00179881
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Memorial Hospital:

Brain stem glioma

Study placed in the following topic categories:

Thalidomide
Brain Stem Neoplasms
Brain Stem neoplasms
Central Nervous System Diseases
Carboplatin
Central Nervous System Neoplasms
Brain Diseases

Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Nervous System Diseases
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Angiogenesis Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Infratentorial Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Neoplasms, Neuroepithelial
Leprostatic Agents

ClinicalTrials.gov processed this record on January 14, 2009