Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003632
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Central Nervous System Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of Intensive Methotrexate and Cytarabine Followed by High Dose Beam Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 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 combination chemotherapy plus peripheral stem cell transplantation in treating patients with newly diagnosed CNS lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with newly diagnosed CNS lymphoma
Detailed Description:
OBJECTIVES I Assess the efficacy and treatment-related toxicity of high-dose chemotherapy comprising carmustine etoposide cytarabine and melphalan followed by autologous peripheral blood stem cell transplantation in patients with primary central nervous system lymphoma II Determine the safety of this regimen in these patients III Determine the efficacy of this regimen in terms of 2-year disease-free survival in these patients IV Assess neurologic outcome using serial neurologic examinations in patients treated with this regimen
OUTLINE Induction therapy Patients receive methotrexate MTX IV over 2 hours once on weeks 1 3 5 and 7 Patients who respond to treatment receive a fifth dose of MTX on week 9 followed by cytarabine ARA-C IV over 3 hours beginning 3 days after completion of MTX infusion and continuing daily for 2 days Filgrastim G-CSF is administered daily beginning 2 days after completion of ARA-C infusion and continuing until harvest of peripheral blood stem cells PBSC Patients receive a second course of ARA-C IV beginning 1 month after completion of the first course of ARA-C and continuing daily for 2 days G-CSF is then administered daily for about 2 weeks High-dose chemotherapytransplantation Patients with stable or responding disease after induction therapy receive high-dose carmustine IV over 1-2 hours on day -7 etoposide IV over 1 hour every 12 hours and ARA-C IV every 12 hours on days -6 to -3 and melphalan IV on day -2 PBSC are reinfused on day 0 Patients receive G-CSF beginning on day 1 and continuing until blood counts recover Patients are followed monthly for 3 months every 3 months for 9 months every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 3 years
OUTLINE Induction therapy Patients receive methotrexate MTX IV over 2 hours once on weeks 1 3 5 and 7 Patients who respond to treatment receive a fifth dose of MTX on week 9 followed by cytarabine ARA-C IV over 3 hours beginning 3 days after completion of MTX infusion and continuing daily for 2 days Filgrastim G-CSF is administered daily beginning 2 days after completion of ARA-C infusion and continuing until harvest of peripheral blood stem cells PBSC Patients receive a second course of ARA-C IV beginning 1 month after completion of the first course of ARA-C and continuing daily for 2 days G-CSF is then administered daily for about 2 weeks High-dose chemotherapytransplantation Patients with stable or responding disease after induction therapy receive high-dose carmustine IV over 1-2 hours on day -7 etoposide IV over 1 hour every 12 hours and ARA-C IV every 12 hours on days -6 to -3 and melphalan IV on day -2 PBSC are reinfused on day 0 Patients receive G-CSF beginning on day 1 and continuing until blood counts recover Patients are followed monthly for 3 months every 3 months for 9 months every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| MSKCC-98086 | None | None | None |
| NCI-G98-1481 | None | None | None |