Brain Stem Neoplasms, Primary Clinical Trial
Official title:
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
| NCT number | NCT00179881 |
| Other study ID # | CNS 1099 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | December 1999 |
| Est. completion date | April 2007 |
| Verified date | February 2019 |
| Source | Ann & Robert H Lurie Children's Hospital of Chicago |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | April 2007 |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 21 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Memorial Hospital | Chicago | Illinois |
| United States | Children's Medical Center | Dayton | Ohio |
| United States | Children's Hospitals and Clinics | Minneapolis | Minnesota |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Washington University Medical Center | Saint Louis | Missouri |
| United States | Children's Hospitals and Clinics | Saint Paul | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen. | |||
| Primary | To determine the overall survival and progression free survival of patients with recurrent brain stem glioma. | |||
| Primary | To determine the toxicity of this drug regimen. | |||
| Secondary | 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. | |||
| Secondary | To formulate experimentally derived hypothesis in order to establish a basis for future investigational studies. |