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Home > "C" Clinical Trials Conditions > Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor  Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor
For Condition: childhood rhabdomyosarcoma,Neuroblastoma,Retinoblastoma,childhood brain tumor
Status: No longer recruiting
Sponsor(s): Kaplan Cancer Center ,
Synopsis: 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.
Details: 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 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.)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /10 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanFinlay, Study Chair, Kaplan Cancer Center
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Winthrop University Hospital
Mineola, New York, 11501
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Canada
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Children's Hospital
Buenos Aires, , 1425
Argentina
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Omaha
Omaha, Nebraska, 68114
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
United States
Beth Israel Hospital North
New York City, New York, 10128
United States
Maine Children's Cancer Program
Scarborough, Maine, 04074-9308
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Additional Information:
Study ID Numbers: CDR0000066174; NYU-P9712,NCI-V98-1400
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003273
Other Neuroblastoma Studies:
1. Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
2. Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
3. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor
4. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
5. Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma
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Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor
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