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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002944 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: lomustine Drug: procarbazine hydrochloride Drug: thioguanine Drug: vincristine sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old |
| Estimated Enrollment: | 340 |
| Study Start Date: | April 1997 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to site of disease, status at entry, and pathology. Patients are randomized to one of two treatment arms. Patients with neurofibromatosis are nonrandomly assigned to arm II.
PROJECTED ACCRUAL: A total of 280-340 patients will be accrued over 4 years.
Eligibility| Ages Eligible for Study: | up to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed low grade residual astrocytomas or other eligible residual tumors of the brain interpreted as low grade (WHO grades I and II) such as the following:
Glial Tumors
Astrocytic tumors
Low grade oligodendroglial tumors
Low grade mixed gliomas
Neuronal Tumors
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 129 Study Locations| Study Chair: | Joann Ater, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000065394, COG-A9952, CCG-A9952, POG-A9952, CCG-9952 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002944 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood brain stem glioma recurrent childhood visual pathway glioma recurrent childhood cerebellar astrocytoma |
recurrent childhood cerebral astrocytoma childhood low-grade cerebellar astrocytoma childhood low-grade cerebral astrocytoma |
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Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Nervous System Diseases Lomustine Thioguanine Vincristine Antimitotic Agents Central Nervous System Neoplasms |
Carboplatin Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Procarbazine Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Nervous System Neoplasms |