Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Brain Stem Neoplasms, Primary Neoplasms, Brain Stem

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Carboplatin

Intervention Type DRUG

Thalomid

Intervention Type DRUG

External Beam Radiation Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No