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NCT Number: NCT00179881

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.

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Key information

Conditions

Brain Stem Neoplasms, Primary Brain Diseases Brain Neoplasms Brain Stem Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Infratentorial Neoplasms Neoplasms Neoplasms by Site Neoplasms, Brain Stem Nervous System Diseases Nervous System Neoplasms

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

carboplatin

Drug

Thalomid

Drug

External Beam Radiation Therapy

Procedure

Primary outcomes

  1. To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.

  2. To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.

  3. To determine the toxicity of this drug regimen.

Secondary outcomes

  1. 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.

  2. To formulate experimentally derived hypothesis in order to establish a basis for future investigational studies.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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