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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00352495 |
Purpose
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 |
|---|---|---|
|
Brain and Central Nervous System Tumors Neurofibromatosis Type 1 |
Drug: carboplatin Drug: vinblastine sulfate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Primary Completion Date: | September 2011 (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.
Eligibility| 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:
Contacts and Locations
Show 21 Study Locations| Study Chair: | Regina Jakacki, MD | Children's Hospital of Pittsburgh of UPMC |
| Investigator: | Eric Bouffet, MD, MRCP | The Hospital for Sick Children |
More Information
| ClinicalTrials.gov Identifier: | NCT00352495 History of Changes |
| Other Study ID Numbers: | CDR0000483184, COG-ADVL0515 |
| Study First Received: | July 13, 2006 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United States: Federal Government |
|
childhood low-grade cerebral astrocytoma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma childhood oligodendroglioma |
neurofibromatosis type 1 recurrent childhood visual pathway and hypothalamic glioma untreated childhood visual pathway and hypothalamic glioma |
|
Glioma Nervous System Neoplasms Neurofibromatosis 1 Osteitis Fibrosa Cystica Neurofibromatoses Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
Neurofibroma Nerve Sheath Neoplasms Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Genetic Diseases, Inborn Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Vinblastine Carboplatin Antineoplastic Agents, Phytogenic |