Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002619
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
1999-11-01
Brief Title:
Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Glioblastoma Multiforme or Brain Stem Tumors
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A TRIAL OF INTENSIVE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL RECONSTITUTION FOR PATIENTS BETWEEN SIX AND SIXTY YEARS OF AGE WITH NON-PROGRESSIVE GLIOBLASTOMA MULTIFORME OR DIFFUSE INTRINSIC BRAINSTEM TUMORS FOLLOWING INITIAL LOCAL-FIELD IRRADIATION
Status:
COMPLETED
Status Verified Date:
2000-06
Last Known Status:
None
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 use different ways to stop tumor cells from dividing so they stop growing or die Bone marrow or peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by autologous bone marrow or peripheral stem cell transplantation in treating patients with glioblastoma multiforme or brain stem tumors
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by autologous bone marrow or peripheral stem cell transplantation in treating patients with glioblastoma multiforme or brain stem tumors
Detailed Description:
OBJECTIVES I Estimate the overall survival progression-free interval and time to progression or recurrence in patients with nondisseminated glioblastoma multiforme or diffuse intrinsic brain stem tumors that are nonprogressive following surgery if feasible and involved-field irradiation and treated with intensive chemotherapy followed by autologous peripheral blood stem cell PBSC or autologous bone marrow ABM rescue II Estimate the toxicity of myeloablative chemotherapy with thiotepa TSPA followed by carboplatin CBDCA in these patients III Evaluate the pharmacokinetic interactions of high-dose CBDCA TSPA and triethylenephosphoramide a metabolite of TSPA and any impact on subsequent toxicity IV Evaluate the effectiveness of autologous stem cells in restoring hematopoiesis following myeloablative therapy
OUTLINE All patients undergo bone marrow or stem cell harvest investigator option no later than 12 weeks after completion of radiotherapy The following acronyms are used ABM Autologous Bone Marrow CBDCA Carboplatin NSC-241240 G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 PBSC Peripheral Blood Stem Cells TSPA Thiotepa NSC-6396 2-Drug Myeloablative Chemotherapy followed by Hematopoietic Rescue TSPA CBDCA followed by ABM or PBSC G-CSF
PROJECTED ACCRUAL 60 patients will be entered over 3 years If more than 5 patients on any arm experience treatment-related mortality accrual will be discontinued
OUTLINE All patients undergo bone marrow or stem cell harvest investigator option no later than 12 weeks after completion of radiotherapy The following acronyms are used ABM Autologous Bone Marrow CBDCA Carboplatin NSC-241240 G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 PBSC Peripheral Blood Stem Cells TSPA Thiotepa NSC-6396 2-Drug Myeloablative Chemotherapy followed by Hematopoietic Rescue TSPA CBDCA followed by ABM or PBSC G-CSF
PROJECTED ACCRUAL 60 patients will be entered over 3 years If more than 5 patients on any arm experience treatment-related mortality accrual will be discontinued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V94-0594 | None | None | None |
| NYU-97-8 | None | None | None |
| MSKCC-94101 | None | None | None |