Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003101
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Bone Marrow Transplantation or Peripheral Stem Cell Transplantation in Treating Patients With Oligodendroglioma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Combining more than one drug and combining chemotherapy with autologous bone marrow transplantation or peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus bone marrow transplantation or peripheral stem cell transplantation in treating patients who have oligodendroglioma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus bone marrow transplantation or peripheral stem cell transplantation in treating patients who have oligodendroglioma
Detailed Description:
OBJECTIVES
Determine the duration of response in patients with newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with intensive chemotherapy supported by autologous transplantation
Determine the neurological and systemic toxic effects of this regimen in these patients
Determine the relationship of 1p loss of heterozygosity on radiographic response progression-free survival and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Mobilization and stem cell harvest Patients receive filgrastim G-CSF subcutaneously daily for up to 7 days followed by peripheral blood stem cell PBSC or bone marrow BM harvest
Induction therapy All patients then receive induction therapy PCV comprising of oral lomustine on day 1 vincristine IV on days 8 and 29 and oral procarbazine on days 8-21 Treatment repeats every 42 days in the absence of progressive disease or unacceptable toxicity Patients with prior complete resections receive 3 courses of PCV then proceed to high-dose chemotherapy and transplantation as described below provided tumor has not recurred Patients with prior partial resections or biopsies receive 2 courses of PCV and are assessed for response those who achieve complete response CR or major partial response PR receive 1 more course of PCV Patients who achieve partial response or have stable disease receive 2 more courses of PCV and are reassessed
High-dose chemotherapy and transplantation Patients who achieve CR or PR receive thiotepa IV on days -8 to -6 and busulfan IV over 2 hours on day -5 to -3 Patients undergo autologous BM or PBSC transplantation on day 0
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 3-5 years
Determine the duration of response in patients with newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with intensive chemotherapy supported by autologous transplantation
Determine the neurological and systemic toxic effects of this regimen in these patients
Determine the relationship of 1p loss of heterozygosity on radiographic response progression-free survival and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Mobilization and stem cell harvest Patients receive filgrastim G-CSF subcutaneously daily for up to 7 days followed by peripheral blood stem cell PBSC or bone marrow BM harvest
Induction therapy All patients then receive induction therapy PCV comprising of oral lomustine on day 1 vincristine IV on days 8 and 29 and oral procarbazine on days 8-21 Treatment repeats every 42 days in the absence of progressive disease or unacceptable toxicity Patients with prior complete resections receive 3 courses of PCV then proceed to high-dose chemotherapy and transplantation as described below provided tumor has not recurred Patients with prior partial resections or biopsies receive 2 courses of PCV and are assessed for response those who achieve complete response CR or major partial response PR receive 1 more course of PCV Patients who achieve partial response or have stable disease receive 2 more courses of PCV and are reassessed
High-dose chemotherapy and transplantation Patients who achieve CR or PR receive thiotepa IV on days -8 to -6 and busulfan IV over 2 hours on day -5 to -3 Patients undergo autologous BM or PBSC transplantation on day 0
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 3-5 years
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-G97-1335 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065833 | REGISTRY | None | None |