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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 March 2015 |
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Main ID: |
NCT00031577 |
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Date of registration:
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08/03/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
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Scientific title:
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A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood |
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Date of first enrolment:
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August 1999 |
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Target sample size:
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11 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00031577 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Jean B. Belasco, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Newly diagnosed, diffuse, intrinsic brain stem glioma by clinical examination and
magnetic resonance imaging (MRI)
- Histologic verification not required
- Intrinsic (more than 50% intra-axial) involvement of the pons, pons and medulla,
pons and midbrain, or entire brain stem allowed
- Contiguous involvement of the thalamus or upper cervical cord allowed
PATIENT CHARACTERISTICS:
Age:
- 3 to 21 at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm3
- Platelet count greater than 100,000/mm3
- Hemoglobin greater than 10.0 g/dL
Hepatic:
- Bilirubin less than 1.5 times normal
- serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase
(SGPT) less than 2.5 times normal
Renal:
- Creatinine less than 1.5 times normal
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use a highly effective method of contraception for female
patients or barrier contraception for male patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- Concurrent corticosteroid therapy for increased intracranial pressure allowed
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent cytochrome P450-inducing anticonvulsants (e.g., phenytoin or
carbamazepine) during paclitaxel therapy
- Other concurrent anticonvulsants (e.g., valproic acid) for pre-existing seizure
disorder allowed
Age minimum:
3 Years
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Brain and Central Nervous System Tumors
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Intervention(s)
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Radiation: radiation therapy
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Drug: paclitaxel
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Secondary ID(s)
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NCI-V01-1677
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BMS-CHP-623
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1999-6-1780
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CDR0000069064
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CHP-623
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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