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
  Purpose

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 Intervention Phase
Brain Stem Neoplasms, Primary
Neoplasms, Brain Stem
Drug: Carboplatin
Drug: Thalomid
Procedure: External Beam Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

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.

Estimated Enrollment: 47
Study Start Date: December 1999
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179881

Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Minnesota
Children's Hospitals and Clinics
Minneapolis, Minnesota, United States, 55404
Children's Hospitals and Clinics
Saint Paul, Minnesota, United States, 55404
United States, Missouri
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Ohio
Children's Medical Center
Dayton, Ohio, United States, 45404
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Stewart Goldman, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Dr. Stewart Goldman, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179881     History of Changes
Other Study ID Numbers: CNS 1099
Study First Received: September 12, 2005
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Brain stem glioma

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Glioma
Brain Stem Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Infratentorial Neoplasms
Thalidomide
Carboplatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014