Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor

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Brief Title

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor

Official Title

Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation With Myeloablative Chemotherapy (Thiotepa, Etoposide and Carboplatin) and Autologous Stem Cell Rescue

Brief Summary

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of different regimens of combination
      chemotherapy followed by peripheral stem cell transplantation in treating children who have
      newly diagnosed brain tumor.
    

Detailed Description

      OBJECTIVES:

        -  Investigate the toxicity of and response rate to an intensification of an induction
           chemotherapy regimen (regimen A: cisplatin, vincristine, cyclophosphamide, and
           etoposide) by incorporation of high-dose methotrexate with leucovorin calcium rescue in
           patients with primitive neuroectodermal tumors and evidence of leptomeningeal
           dissemination (M1, M2, or M3).

        -  Investigate the toxicity of and response rate to a new dose intensive induction
           chemotherapy regimen (regimen C: vincristine, carboplatin, and temozolomide) in children
           under ten years of age who are newly diagnosed with either high grade gliomas or diffuse
           intrinsic pontine tumors. (Regimen B closed to accrual effective 3/30/2000; regimen C
           open to accrual effective 7/21/2000)

        -  Investigate the feasibility of utilizing regimen C chemotherapy followed by
           consolidation with myeloablative chemotherapy and autologous stem cell (either bone
           marrow and/or peripheral blood) rescue in these patients. (Regimen B closed to accrual
           effective 3/30/2000; regimen C open to accrual effective 7/21/2000)

        -  Investigate the toxicity of and response rate to an intensification of induction regimen
           A chemotherapy by incorporation of high-dose methotrexate with leucovorin calcium rescue
           in patients with primitive neuroectodermal tumors and evidence of leptomeningeal
           dissemination (M1, M2, or M3).

        -  Estimate the time to disease progression and the pattern of relapse in patients who do
           not have radiographic or cytologic evidence of residual disease at the time of
           consolidation chemotherapy and who, therefore, do not receive post consolidation
           irradiation.

        -  Estimate the time to disease progression and the pattern of relapse in patients who have
           radiographic or cytologic evidence of residual disease at the time of consolidation
           chemotherapy and who, therefore, receive post consolidation irradiation.

        -  Assess the morbidity and mortality of the consolidation chemotherapy regimen following
           either regimen C or the intensified regimen A in these patients. (Regimen B closed to
           accrual effective 3/30/2000; regimen C open to accrual effective 7/21/2000)

        -  Assess the impact that irradiation avoidance or the administration of reduced volume
           craniospinal and/or focused field local irradiation has on neuropsychometric,
           endocrinological functions, and physical growth.

      OUTLINE: This is a two regimen study based on disease characteristics.

      Patients in regimens A, B, and C undergo leukapheresis after receiving filgrastim (G-CSF) by
      subcutaneous (SC) injections.

        -  Regimen A: Patients without evidence of neuraxis dissemination receive five 21 day
           courses of the following chemotherapy: cisplatin IV over 6 hours on day 0; etoposide and
           cyclophosphamide IV over 1 hour on days 1 and 2; vincristine IV on days 0, 7, and 14 of
           courses 1, 2, and 3; and G-CSF SC beginning on day 3 of each course and continuing until
           blood counts recover or up to 48 hours before the start of the next course. Patients
           with evidence of neuraxis dissemination also receive high-dose methotrexate IV over 4
           hours on day 3 and leucovorin calcium orally or by IV bolus starting 24 hours prior to
           methotrexate and continuing every 6 hours until methotrexate levels have diminished.

        -  Regimen B (closed to accrual effective 3/30/2000): Patients receive three 21-28 day
           courses of the following chemotherapy: vincristine IV on days 0, 7, and 14 of each
           course; carboplatin IV over 4 hours on days 3 and 4 of each course; oral procarbazine
           daily on days 0-4; oral lomustine on days 3 and 4; and G-CSF SC daily beginning 24 hours
           following the last dose of carboplatin and continuing until blood counts recover or up
           to 48 hours before the start of the next course. On day 7 of each course, patients also
           receive peripheral blood stem cell (PBSC) reinfusion following chemotherapy. Oral
           lomustine is administered only for the first two courses.

        -  Regimen C (open to accrual effective 07/21/2000): Patients receive four 28 day courses
           of the following chemotherapy: carboplatin IV over 4 hours on days 0 and 1 of each
           course; vincristine IV on days 0, 7, and 14 of the first three courses only; oral
           temozolomide daily on days 0-4; and G-CSF SC daily beginning on day 5 and continuing
           until blood counts recover.

      After regimen A, B, or C and in the absence of disease progression, patients undergo
      consolidation myeloablative chemotherapy by receiving carboplatin IV over 4 hours on days -8,
      -7, and -6, and then thiotepa IV over 3 hours followed by etoposide IV on days -5, -4, and
      -3. Patients with malignant gliomas or unbiopsied diffuse intrinsic pontine tumors do not
      receive etoposide. On day 0, patients are reinfused with autologous PBSC. Following recovery
      from consolidation chemotherapy, patients with radiographic or cytologic evidence of residual
      disease undergo radiotherapy.

      Patients are followed at 3 months, then every 3 months for the first 2 years, then every 6
      months for years 2-4, and then annually thereafter.

      PROJECTED ACCRUAL: Approximately 96 patients (73 for regimen A and 23 for regimen C) will be
      accrued for this study. (Regimen B closed to accrual effective 3/30/2000.)
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Brain and Central Nervous System Tumors

Intervention

filgrastim


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

0

Start Date

November 1997



Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed malignant, newly diagnosed brain tumor

        Regimen A:

          -  Posterior fossa medulloblastoma/primitive neuroectodermal tumor (PNET):

               -  All stages, under 3 years at diagnosis OR

               -  High stage (local residual tumor postoperatively and/or neuraxis or extraneural
                  dissemination), 3-10 years at diagnosis

          -  Supratentorial PNET, pineoblastoma, cerebral neuroblastoma, ependymoblastoma,
             medulloepithelioma, medullomyoblastoma:

               -  All stages, under 10 years at diagnosis

          -  Brainstem PNET:

               -  All stages, irrespective of extent of resection, under 10 years at diagnosis

          -  Ependymoma or anaplastic ependymoma:

               -  All stages, any location (except primary spinal cord ependymoma), under 3 years
                  at diagnosis OR

               -  Local residual tumor postoperatively and/or neuraxis dissemination, any location,
                  3-10 years at diagnosis

          -  Supratentorial ependymoma:

               -  All stages, irrespective of extent of resection, under 10 years at diagnosis,
                  excluding gross totally resected (confirmed by postoperative MRI) low grade
                  ependymoma not invading the ventricular system

          -  Metastatic retinoblastoma:

               -  Previously untreated (except for cryosurgery or laser surgery), under 10 years at
                  presentation of metastatic disease

          -  Primary atypical teratoid/rhabdoid tumors of the CNS:

               -  Under 10 years at diagnosis

          -  Choroid plexus carcinoma:

               -  Incompletely resected, all sites, under 10 years at diagnosis

        Regimen C:

          -  Anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma,
             anaplastic ganglioglioma, other anaplastic mixed gliomas:

               -  Under 10 years at diagnosis

          -  Diffuse intrinsic pontine tumors:

               -  Unbiopsied, under 10 years at diagnosis

        The following diagnoses are not eligible:

          -  Myxopapillary ependymoma of the spinal cord, low grade brainstem astrocytoma, primary
             CNS lymphoma or solid leukemic lesion (i.e., chloroma, granulocytic sarcoma), or
             primary CNS germ cell tumor

        PATIENT CHARACTERISTICS:

        Age:

          -  Under 10 at diagnosis

        Performance status:

          -  Not specified

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Bilirubin less than 1.5 mg/dL

          -  SGPT less than 2.5 times upper limit of normal

        Renal:

          -  Creatinine clearance greater than 60 mL/min

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior chemotherapy

        Endocrine therapy:

          -  Prior corticosteroids allowed

          -  No concurrent corticosteroids for the sole purpose of antiemesis

        Radiotherapy:

          -  No prior radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  Recovered from prior surgery
      

Gender

All

Ages

N/A - 10 Years

Accepts Healthy Volunteers

No

Contacts

Jonathan L. Finlay, MB, ChB, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT00003273

Organization ID

CDR0000066174

Secondary IDs

NYU-P9712

Responsible Party

Sponsor

Study Sponsor

NYU Langone Health


Study Sponsor

Jonathan L. Finlay, MB, ChB, Study Chair, NYU Langone Health


Verification Date

November 2015