Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392886
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2006-10-25
Brief Title:
Combination Chemotherapy With or Without Etoposide Followed By an Autologous Stem Cell Transplant in Treating Young Patients With Previously Untreated Malignant Brain Tumors
Sponsor:
Childrens Hospital Los Angeles
Organization:
National Cancer Institute NCI
Study Overview
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 and Carboplatin With or Without Etoposide and Autologous Stem Cell Rescue HEAD START III
Status:
UNKNOWN
Status Verified Date:
2010-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by chemotherapy This may allow more chemotherapy to be given so that more tumor cells are killed
PURPOSE This phase III trial is studying how well giving combination chemotherapy with or without etoposide followed by an autologous stem cell transplant works in treating young patients with previously untreated malignant brain tumors
PURPOSE This phase III trial is studying how well giving combination chemotherapy with or without etoposide followed by an autologous stem cell transplant works in treating young patients with previously untreated malignant brain tumors
Detailed Description:
OBJECTIVES
Primary
Determine the 2-year event-free survival EFS and overall survival OS of pediatric patients with previously untreated nondisseminated medulloblastoma 4 years of age disseminated medulloblastoma 10 years of age or noncerebellar primitive neuroectodermal tumors PNET disseminated or non-disseminated treated with induction chemotherapy followed by consolidation with myeloablative chemotherapy and autologous hematopoietic stem cell rescue
Determine the toxicity of this regimen in these patients
Determine the mortality of patients treated with this regimen
Secondary
Determine the complete and partial response rates after completion of induction chemotherapy in these patients stratified according to pathology medulloblastoma vs noncerebellar PNET vs high-grade gliomas vs atypical teratoidrhabdoid tumors vs choroid plexus carcinomas and atypical papillomas vs ependymomas
Describe the EFS and OS of these patients stratified according to additional diagnoses atypical teratoidrhabdoid tumors vs choroid plexus carcinomas and atypical choroid plexus papillomas vs ependymomas vs high-grade gliomas
Describe the time to progression and patterns of relapse in these patients stratified by diagnosis and radiotherapy received 6 years of age with evidence of no residual tumor pre-transplant and no post-transplant consolidation radiotherapy vs 6 years of age with residual tumor present pre-transplant treated with post-transplant consolidation radiotherapy vs 6 years of age treated with post-transplant consolidation radiotherapy
Determine the neuropsychometric function endocrinologic function and physical growth in these patients stratified according to radiotherapy received none vs reduced-volume craniospinal radiotherapy vs focused local-field radiotherapy
OUTLINE This is a pilot study Patients are stratified according to type of tumor nonglial vs glial and diffuse pontine
Regimen C patients with glial tumors
Stem cell harvesting bone marrow andor peripheral blood Patients undergo leukapheresis or bone marrow aspiration to collect bone marrow or peripheral blood stem cells prior to beginning induction chemotherapy or after the first course of induction chemotherapy
Induction chemotherapy Patients receive vincristine IV on days 1 8 and 15 of courses 1-3 oral temozolomide once daily on days 1-5 and carboplatin IV over 4 hours on days 1 and 2 Patients also receive G-CSF SC beginning on day 6 and continuing until blood counts recover Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with unresectable bulky disease and corticosteroid dependence are removed from study All other patients proceed to consolidation chemotherapy
Consolidation chemotherapy Patients receive carboplatin IV over 4 hours on days -8 to -6 and thiotepa IV over 3 hours on days -5 to -3
Autologous bone marrow or peripheral blood stem cell transplantation Patients undergo reinfusion of bone marrow or peripheral blood stem cells on day 0 Patients also receive G-CSF SC beginning on day 1 and continuing until blood counts recover
Radiotherapy Beginning within 6 weeks after stem cell transplantation patients 6 years of age at diagnosis undergo radiotherapy once daily 5 days a week for 4-6 weeks in the absence of disease progression or unacceptable toxicity Patients 6 years of age undergo radiotherapy if there is evidence of tumor remaining after completion of induction chemotherapy
Regimen D2 patients with nonglial tumors
Stem cell harvesting bone marrow andor peripheral blood Patients undergo leukapheresis or bone marrow aspiration to collect bone marrow or peripheral blood stem cells prior to beginning induction chemotherapy or after the first course of induction chemotherapy
Induction chemotherapy
Courses 1 3 and 5 28 days per course Patients receive cisplatin IV over 6 hours on day 1 cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 2 and 3 high-dose methotrexate IV over 4 hours on day 4 and filgrastim G-CSF subcutaneously SC beginning on day 5 and continuing until blood counts recover Patients also receive vincristine IV on days 1 8 and 15 of courses 1 and 3
Courses 2 and 4 28 days per course Patients receive oral temozolomide once daily on days 1-5 oral etoposide once daily on days 1-10 cyclophosphamide IV over 1 hour on days 11 and 12 and G-CSF SC beginning on day 13 and continuing until blood counts recover Patients also receive vincristine IV on days 1 8 and 15 of course 2
Patients with unresectable bulky disease and corticosteroid dependence are removed from study All other patients proceed to consolidation chemotherapy
Consolidation chemotherapy Patients receive carboplatin IV over 4 hours on days -8 to -6 and thiotepa IV over 3 hours and etoposide IV over 3 hours on days -5 to -3
Autologous bone marrow or peripheral blood stem cell transplantation Patients undergo re-infusion of bone marrow or peripheral blood stem cells on day 0 Patients also receive G-CSF SC beginning on day 1 and continuing until blood counts recover
RadiotherapyPatients undergo radiotherapy as in regimen C Patients in both regimens undergo neuropsychological testing after induction chemotherapy but before consolidation chemotherapy and then at 18 36 and 54 months after completion of study treatment Neuropsychometric and neuroendocrine testing is performed before and after radiotherapy Quality of life is also assessed periodically
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study
Primary
Determine the 2-year event-free survival EFS and overall survival OS of pediatric patients with previously untreated nondisseminated medulloblastoma 4 years of age disseminated medulloblastoma 10 years of age or noncerebellar primitive neuroectodermal tumors PNET disseminated or non-disseminated treated with induction chemotherapy followed by consolidation with myeloablative chemotherapy and autologous hematopoietic stem cell rescue
Determine the toxicity of this regimen in these patients
Determine the mortality of patients treated with this regimen
Secondary
Determine the complete and partial response rates after completion of induction chemotherapy in these patients stratified according to pathology medulloblastoma vs noncerebellar PNET vs high-grade gliomas vs atypical teratoidrhabdoid tumors vs choroid plexus carcinomas and atypical papillomas vs ependymomas
Describe the EFS and OS of these patients stratified according to additional diagnoses atypical teratoidrhabdoid tumors vs choroid plexus carcinomas and atypical choroid plexus papillomas vs ependymomas vs high-grade gliomas
Describe the time to progression and patterns of relapse in these patients stratified by diagnosis and radiotherapy received 6 years of age with evidence of no residual tumor pre-transplant and no post-transplant consolidation radiotherapy vs 6 years of age with residual tumor present pre-transplant treated with post-transplant consolidation radiotherapy vs 6 years of age treated with post-transplant consolidation radiotherapy
Determine the neuropsychometric function endocrinologic function and physical growth in these patients stratified according to radiotherapy received none vs reduced-volume craniospinal radiotherapy vs focused local-field radiotherapy
OUTLINE This is a pilot study Patients are stratified according to type of tumor nonglial vs glial and diffuse pontine
Regimen C patients with glial tumors
Stem cell harvesting bone marrow andor peripheral blood Patients undergo leukapheresis or bone marrow aspiration to collect bone marrow or peripheral blood stem cells prior to beginning induction chemotherapy or after the first course of induction chemotherapy
Induction chemotherapy Patients receive vincristine IV on days 1 8 and 15 of courses 1-3 oral temozolomide once daily on days 1-5 and carboplatin IV over 4 hours on days 1 and 2 Patients also receive G-CSF SC beginning on day 6 and continuing until blood counts recover Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with unresectable bulky disease and corticosteroid dependence are removed from study All other patients proceed to consolidation chemotherapy
Consolidation chemotherapy Patients receive carboplatin IV over 4 hours on days -8 to -6 and thiotepa IV over 3 hours on days -5 to -3
Autologous bone marrow or peripheral blood stem cell transplantation Patients undergo reinfusion of bone marrow or peripheral blood stem cells on day 0 Patients also receive G-CSF SC beginning on day 1 and continuing until blood counts recover
Radiotherapy Beginning within 6 weeks after stem cell transplantation patients 6 years of age at diagnosis undergo radiotherapy once daily 5 days a week for 4-6 weeks in the absence of disease progression or unacceptable toxicity Patients 6 years of age undergo radiotherapy if there is evidence of tumor remaining after completion of induction chemotherapy
Regimen D2 patients with nonglial tumors
Stem cell harvesting bone marrow andor peripheral blood Patients undergo leukapheresis or bone marrow aspiration to collect bone marrow or peripheral blood stem cells prior to beginning induction chemotherapy or after the first course of induction chemotherapy
Induction chemotherapy
Courses 1 3 and 5 28 days per course Patients receive cisplatin IV over 6 hours on day 1 cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 2 and 3 high-dose methotrexate IV over 4 hours on day 4 and filgrastim G-CSF subcutaneously SC beginning on day 5 and continuing until blood counts recover Patients also receive vincristine IV on days 1 8 and 15 of courses 1 and 3
Courses 2 and 4 28 days per course Patients receive oral temozolomide once daily on days 1-5 oral etoposide once daily on days 1-10 cyclophosphamide IV over 1 hour on days 11 and 12 and G-CSF SC beginning on day 13 and continuing until blood counts recover Patients also receive vincristine IV on days 1 8 and 15 of course 2
Patients with unresectable bulky disease and corticosteroid dependence are removed from study All other patients proceed to consolidation chemotherapy
Consolidation chemotherapy Patients receive carboplatin IV over 4 hours on days -8 to -6 and thiotepa IV over 3 hours and etoposide IV over 3 hours on days -5 to -3
Autologous bone marrow or peripheral blood stem cell transplantation Patients undergo re-infusion of bone marrow or peripheral blood stem cells on day 0 Patients also receive G-CSF SC beginning on day 1 and continuing until blood counts recover
RadiotherapyPatients undergo radiotherapy as in regimen C Patients in both regimens undergo neuropsychological testing after induction chemotherapy but before consolidation chemotherapy and then at 18 36 and 54 months after completion of study treatment Neuropsychometric and neuroendocrine testing is performed before and after radiotherapy Quality of life is also assessed periodically
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHLA-HEAD-START-III | None | None | None |
| CHLA-HSIII | None | None | None |
| CHLA-2004-020 | None | None | None |
| CHLA-04020 | None | None | None |
| UMN-MT2004-06 | None | None | None |