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Combination Chemotherapy in Treating Children With Progressive Brain Tumors
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00002944
First received: November 1, 1999
Last updated: September 6, 2013
Last verified: September 2013
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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 Tumors Central Nervous System Tumors | Drug: carboplatin Drug: lomustine Drug: procarbazine hydrochloride Drug: thioguanine Drug: vincristine sulfate | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old |
Resource links provided by NLM:
MedlinePlus related topics:
Brain Tumors
Genetic and Rare Diseases Information Center resources:
Glioma
Optic Pathway Glioma
Childhood Brain Stem Glioma
Cerebellar Astrocytoma, Childhood
Cerebral Astrocytoma, Childhood
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- Event Free Survival [ Time Frame: Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years ]Compare the event-free survival as a result of treatment with either CV or TPCV
Secondary Outcome Measures:
- Survival [ Time Frame: 5 years ]Defined as the time to death from any cause.
| Enrollment: | 428 |
| Study Start Date: | April 1997 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Regimen A (CV Chemotherapy)
Induction will consist of 10 weeks of therapy (carboplatin, vincristine sulfate),followed by 2 weeks without chemotherapy. Induction should only be interrupted in the event of grade 3 neurotoxicity, grade 2 renal toxicity, grade 4 hematologic toxicity, or tumor progression. Maintenance-Four Courses (2 cycles/course) commences on Day 84 (week 12) of Induction or when peripheral counts recover with ANC >1,000/$L and platelet count >100,000/$L. Each cycle will consist of 4 weekly doses of carboplatin, three weekly doses of vincristine sulfate (given concomitantly with the first 3 weeks of carboplatin), followed by two weeks of rest for a total of 6 weeks. Maintenance will continue for a total of 8 cycles.
|
Drug: carboplatin
Given IV
Other Names:
Drug: vincristine sulfate
Given PO and IV
Other Names:
|
|
Experimental: Regimen B (TPCV Chemotherapy)
Each cycle of chemotherapy consists of 4 days of oral chemotherapy (Thioguanine, procarbazine hydrochloride, Lomustine and Vincristine sulfate beginning Day 0, followed by vincristine sulfate IV on Days 14 and 28. The cycle is repeated every 6 weeks (42 days). A total of 8 cycles will be given.
|
Drug: lomustine
Given IV
Other Names:
Drug: procarbazine hydrochloride
Given PO
Other Names:
Drug: thioguanine
Given PO
Other Names:
Drug: vincristine sulfate
Given PO and IV
Other Names:
|
Detailed Description:
OBJECTIVES:
- Compare the event free survival as a result of treatment with carboplatin and vincristine versus thioguanine, procarbazine, lomustine, and vincristine in children with progressive brain tumors.
- Estimate tumor response rates to each regimen of chemotherapy in these patients.
- Determine toxic effects and quality of life of children treated with each regimen of chemotherapy.
- Investigate biological and clinical factors which may predict tumor response and early progression (tumor size, location, pathologic subtype, cytogenetics, and proliferative index by MIB-1 (Ki67)) in these patients.
- Investigate factors contributing to neuropsychological and endocrine status of children with brain tumors treated without irradiation.
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.
- Arm I: Patients receive induction with carboplatin and vincristine for 10 weeks followed by 2 weeks of rest. Induction is followed by 8 courses of maintenance beginning on day 84 of induction or upon hematopoietic recovery. Each course consists of 4 weekly doses of carboplatin and 3 weekly doses of vincristine (given concurrently with the first 3 weeks of carboplatin), followed by 2 weeks of rest.
- Arm II: Patients receive oral thioguanine, procarbazine, and lomustine on days 0-4, followed by vincristine IV on days 14 and 28. Treatment continues every 6 weeks for a maximum of 8 courses.
PROJECTED ACCRUAL: A total of 280-340 patients will be accrued over 4 years.
Eligibility| Ages Eligible for Study: | up to 9 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 astrocytoma (variants: fibrillary, protoplasmic, gemistocytic)
- Pilocytic astrocytoma
- Pleomorphic xanthoastrocytomas
- Subependymal giant cell astrocytoma
- Infantile desmoplastic astrocytoma
-
Low grade oligodendroglial tumors
- Low grade oligodendroglioma
-
Low grade mixed gliomas
- Oligo-astrocytoma
-
-
Neuronal Tumors
- Ganglioglioma (excluding tumors with anaplastic astrocytic components)
- Infantile desmoplastic ganglioglioma
- Chiasmatic-hypothalamic tumor without histologic confirmation
-
- All of the following diagnostic tests (radiological or clinical evidence of progression, surgery, or confirmatory MRI) must be carried out within 6 weeks of enrollment into this study
- Progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision (less than 95% or greater than 1.5 cm2) with necessity to begin treatment because of a risk of neurologic impairment with progression
- Chiasmatic lesions that have contiguous extensions of tumor into other regions of the visual pathways demonstrated on contrast MRI will be eligible for study without histopathological confirmation
- Patients with neurofibromatosis who have radiographic diagnosis of chiasmatic-hypothalamic tumor are eligible for the study, without requiring a biopsy confirmation of tumor histology, but not unless tumor progression is documented radiographically
- No intrinsic brain stem tumors of the pons or isolated optic nerve tumors without definitive involvement of the optic chiasm
PATIENT CHARACTERISTICS:
Age:
- Under 10
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3 (arm II)
- Platelet count greater than 100,000/mm^3 (arm II)
Hepatic:
- Not specified
Renal:
- Creatinine less than 1.5 times upper limit of normal for age OR
- Creatinine clearance or radioisotope GFR greater than 70 mL/min or equivalent GFR as determined by the institutional normal range
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for the tumor
Endocrine therapy:
- Prior corticosteroid therapy allowed
Radiotherapy:
- No prior radiotherapy for the tumor
Surgery:
- See Disease characteristics
Other:
- Prior diuretic therapy allowed
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002944
Show 204 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002944
Show 204 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Study Chair: | Joann Ater, MD | M.D. Anderson Cancer Center |
More Information
Publications:
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002944 History of Changes |
| Other Study ID Numbers: |
A9952 CCG-A9952 ( Other Identifier: Children's Cancer Group ) POG-A9952 ( Other Identifier: Pediatric Oncology Group ) CCG-9952 ( Other Identifier: Clinical Trials.gov ) CDR0000065394 ( Other Identifier: Clinical Trials.gov ) |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 6, 2013 |
Keywords provided by Children's Oncology Group:
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Brain Neoplasms Astrocytoma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Carboplatin Vincristine Lomustine Thioguanine Procarbazine Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on July 21, 2017