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NCT00002944 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy in Treating Children With Progressive Brain Tumors

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-09-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
9 Years
sex
ALL
std Ages
  1. CHILD
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: carboplatin
    2. Drug: vincristine sulfate
    label
    Regimen A (CV Chemotherapy)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: lomustine
    2. Drug: procarbazine hydrochloride
    3. Drug: thioguanine
    4. Drug: vincristine sulfate
    label
    Regimen B (TPCV Chemotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Regimen A (CV Chemotherapy)
    description
    Given IV
    name
    carboplatin
    other Names
    1. Paraplatin
    2. NSC-241240
    type
    DRUG
  2. arm Group Labels
    1. Regimen B (TPCV Chemotherapy)
    description
    Given IV
    name
    lomustine
    other Names
    1. CCNU
    2. NSC-79037
    type
    DRUG
  3. arm Group Labels
    1. Regimen B (TPCV Chemotherapy)
    description
    Given PO
    name
    procarbazine hydrochloride
    other Names
    1. Matulane
    2. NSC-77213
    type
    DRUG
  4. arm Group Labels
    1. Regimen B (TPCV Chemotherapy)
    description
    Given PO
    name
    thioguanine
    other Names
    1. 6-TG
    2. NSC-752
    type
    DRUG
  5. arm Group Labels
    1. Regimen A (CV Chemotherapy)
    2. Regimen B (TPCV Chemotherapy)
    description
    Given PO and IV
    name
    vincristine sulfate
    other Names
    1. Oncovin
    2. NSC-675574
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
428
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Compare the event-free survival as a result of treatment with either CV or TPCV
    measure
    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
secondary Outcomes
  1. description
    Defined as the time to death from any cause.
    measure
    Survival
    time Frame
    5 years
Full study description
brief Summary
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.
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.
Source references
references
  1. citation
    Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. doi: 10.1200/JCO.2011.36.6054. Epub 2012 Jun 4.
    pmid
    22665535
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        l of evidence A1</a>]</li></ul></div> <p id="_412" tabindex="-1">The COG reported the results of a randomized phase III trial (<a href="/clinicaltrials/NCT00002944">COG-A9952</a>) that treated children younger than 10 years with low-grade chiasmatic/hypothalamic gliomas without NF1 using one of two regimens: carboplatin
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      cf48a63ebd4e604305ad3fcf86b4d182573a8ad04c8f0d59c7e1b311addad882
      source title
      Childhood Astrocytomas, Other Gliomas, and Glioneuronal/Neuronal Tumors Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 14, 2025
        datetime
        2025-04-14T12:00:00Z
        display
        April 14, 2025

    Preserved source evidence · Not medical advice