Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

This study has been completed.

Sponsor:

Information provided by:

Ann & Robert H Lurie Children's Hospital of Chicago

ClinicalTrials.gov Identifier:

NCT00179881

First received: September 12, 2005

Last updated: June 22, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

June 22, 2011

Start Date ^ICMJE

December 1999

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00179881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Official Title ^ICMJE

Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Brain Stem Neoplasms, Primary
Neoplasms, Brain Stem

Intervention ^ICMJE

Drug: Carboplatin
Drug: Thalomid
Procedure: External Beam Radiation Therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

3 Years to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00179881

Other Study ID Numbers ^ICMJE

CNS 1099

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr. Stewart Goldman, Children's Memorial Hospital

Study Sponsor ^ICMJE

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stewart Goldman, MD

Ann & Robert H Lurie Children's Hospital of Chicago

Information Provided By

Ann & Robert H Lurie Children's Hospital of Chicago

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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