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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: | Allocation: Randomized Primary Purpose: Treatment |
| 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 204 Study Locations| Study Chair: | Joann Ater, MD | M.D. Anderson Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00002944 History of Changes |
| Other Study ID Numbers: | CDR0000065394, COG-A9952, CCG-A9952, POG-A9952, CCG-9952 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 29, 2010 |
| 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 |
|
Astrocytoma Nervous System Neoplasms Central Nervous System Neoplasms Glioma 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 Lomustine Procarbazine |
Thioguanine Vincristine Carboplatin Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |