Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT00179881

Collaborator

(none)

Enrollment

Locations

Duration (Months)

7.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Stem Neoplasms, Primary Neoplasms, Brain Stem	Drug: Carboplatin Drug: Thalomid Procedure: External Beam Radiation Therapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

47 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Study Start Date :

Dec 1, 1999

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016
2	Children's Memorial Hospital	Chicago	Illinois	United States	60614
3	Children's Hospitals and Clinics	Minneapolis	Minnesota	United States	55404
4	Children's Hospitals and Clinics	Saint Paul	Minnesota	United States	55404
5	Washington University Medical Center	Saint Louis	Missouri	United States	63110
6	Children's Medical Center	Dayton	Ohio	United States	45404