Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025558
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Dose Escalation of Temozolomide in Combination With Thiotepa and Carboplatin With Autologous Stem Cell Rescue in Patients With Malignant Brain Tumors With Minimal Residual Disease
Status:
COMPLETED
Status Verified Date:
2011-03
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 Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining temozolomide thiotepa and carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have brain cancer
PURPOSE Phase I trial to study the effectiveness of combining temozolomide thiotepa and carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have brain cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of temozolomide in combination with thiotepa and carboplatin followed by autologous peripheral blood stem cell or bone marrow transplantation in patients with recurrent high-grade brain tumors with minimal residual disease or newly-diagnosed malignant glioma with minimal residual disease following irradiation
OUTLINE This is a dose-escalation study of temozolomide
Patients receive filgrastim G-CSF subcutaneously SC once daily for 3 consecutive days After the third dose of G-CSF patients undergo leukapheresis to collect peripheral blood stem cells PBSC Patients who do not have adequate PBSC may undergo bone marrow harvest
Patients then receive oral temozolomide every 12 hours on days -10 to -6 and thiotepa IV over 3 hours and carboplatin IV over 4 hours on days -5 to -3
PBSC or bone marrow are reinfused on day 0 Beginning on day 1 patients receive G-CSF SC or IV until blood counts recover
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at day 42 at 3 months every 3 months for 2 years every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 18-30 patients will be accrued for this study
Determine the maximum tolerated dose of temozolomide in combination with thiotepa and carboplatin followed by autologous peripheral blood stem cell or bone marrow transplantation in patients with recurrent high-grade brain tumors with minimal residual disease or newly-diagnosed malignant glioma with minimal residual disease following irradiation
OUTLINE This is a dose-escalation study of temozolomide
Patients receive filgrastim G-CSF subcutaneously SC once daily for 3 consecutive days After the third dose of G-CSF patients undergo leukapheresis to collect peripheral blood stem cells PBSC Patients who do not have adequate PBSC may undergo bone marrow harvest
Patients then receive oral temozolomide every 12 hours on days -10 to -6 and thiotepa IV over 3 hours and carboplatin IV over 4 hours on days -5 to -3
PBSC or bone marrow are reinfused on day 0 Beginning on day 1 patients receive G-CSF SC or IV until blood counts recover
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at day 42 at 3 months every 3 months for 2 years every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 18-30 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 |
|---|---|---|---|
| NCI-G01-2022 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-0006H | None | None | None |