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Sponsored by: |
Children's Hospital of Philadelphia |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00031577 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: paclitaxel Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood |
Estimated Enrollment: | 12 |
Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.
Patients receive induction therapy comprising paclitaxel IV over 1 hour once weekly and involved-field radiotherapy (after paclitaxel infusion) once daily, 5 days a week, for 6 weeks.
Beginning 6 weeks after completion of induction therapy, patients may receive maintenance therapy comprising paclitaxel IV over 1 hour once every 3 weeks for a total of 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study within 12-18 months.
Ages Eligible for Study: | 3 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed, diffuse, intrinsic brain stem glioma by clinical examination and MRI
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Egleston, Georgia, United States, 30322 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Chair: | Jean B. Belasco, MD | Children's Hospital of Philadelphia |
Study ID Numbers: | CDR0000069064, CHP-623, BMS-CHP-623, CHP-1999-7-1780, NCI-V01-1677 |
Study First Received: | March 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00031577 |
Health Authority: | United States: Federal Government |
untreated childhood brain stem glioma |
Neuroectodermal Tumors Paclitaxel Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Mitosis Modulators Antimitotic Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic |