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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077207 |
RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive and/or symptomatic low-grade glioma.
Condition | Intervention |
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Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: temozolomide Drug: vincristine sulfate |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas |
Estimated Enrollment: | 50 |
Study Start Date: | July 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | up to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed progressive and/or symptomatic low-grade glioma, including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Murali M. Chintagumpala, MD | Texas Children's Cancer Center |
Study ID Numbers: | CDR0000350005, COG-ACNS0223 |
Study First Received: | February 10, 2004 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077207 |
Health Authority: | United States: Federal Government |
untreated childhood cerebellar astrocytoma untreated childhood visual pathway and hypothalamic glioma childhood spinal cord neoplasm childhood oligodendroglioma childhood low-grade cerebral astrocytoma |
Astrocytoma Spinal cord neoplasm Vincristine Carboplatin Central Nervous System Neoplasms Temozolomide Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Spinal Cord Neoplasms Neuroepithelioma Oligodendroglioma Glioma 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 Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Antineoplastic Agents, Phytogenic |