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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

September 12, 2005
June 22, 2011
December 1999
April 2007   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT00179881 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain Stem Neoplasms, Primary
  • Neoplasms, Brain Stem
  • Drug: Carboplatin
  • Drug: Thalomid
  • Procedure: External Beam Radiation Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
April 2007
April 2007   (final data collection date for primary outcome measure)

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.
Both
3 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179881
CNS 1099
Not Provided
Dr. Stewart Goldman, Children's Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Not Provided
Principal Investigator: Stewart Goldman, MD Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
June 2011

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