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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: | NCT00352495 |
RATIONALE: Drugs used in chemotherapy, such as vinblastine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vinblastine when given together with carboplatin in treating young patients with newly diagnosed or recurrent low-grade glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Neurofibromatosis Type 1 (nf1) |
Drug: carboplatin Drug: vinblastine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas |
Estimated Enrollment: | 18 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of vinblastine. Patients are stratified according to amount of prior therapy (heavily pretreated vs less heavily pretreated).
Patients receive carboplatin IV over 30 minutes on day 1 and vinblastine IV on days 1, 8, 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vinblastine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* low-grade glioma, including 1 of the following subtypes:
Astrocytoma variants
Biopsy proven focal low-grade gliomas of the brainstem with measurable disease allowed
Patients without NF-1 must meet the following criteria:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age, as follows:
PRIOR CONCURRENT THERAPY:
Study Chair: | Regina Jakacki, MD | Children's Hospital of Pittsburgh |
Investigator: | Eric Bouffet, MD, MRCP | The Hospital for Sick Children |
Study ID Numbers: | CDR0000483184, COG-ADVL0515 |
Study First Received: | July 13, 2006 |
Last Updated: | December 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00352495 |
Health Authority: | United States: Federal Government |
childhood low-grade cerebral astrocytoma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma childhood oligodendroglioma |
neurofibromatosis type 1 (NF1) recurrent childhood visual pathway and hypothalamic glioma untreated childhood visual pathway and hypothalamic glioma |
Astrocytoma Vinblastine Carboplatin Central Nervous System Neoplasms Neurodegenerative Diseases Neurofibromatosis type 1 Neurofibromatosis 1 Recurrence Neuroectodermal Tumors Heredodegenerative Disorders, Nervous System Neoplastic Syndromes, Hereditary Neuromuscular Diseases |
Genetic Diseases, Inborn Neurofibroma Peripheral Nervous System Diseases Neoplasms, Germ Cell and Embryonal Neurofibromatoses Neuroepithelioma Oligodendroglioma Glioma Nervous System Neoplasms Nerve Sheath Neoplasms Neurocutaneous Syndromes 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 |