Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Phase 2

Completed

• Conditions: Brain Stem Neoplasms, Primary; Neoplasms, Brain Stem

• Registration Number: NCT00179881
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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 available

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.
To determine the toxicity of this drug regimen.
To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Children's Hospitals and Clinics; 🇺🇸 Saint Paul, Minnesota, United States

Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Children's Medical Center; 🇺🇸 Dayton, Ohio, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States