Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002982
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Older Patients With Refractory or Relapsed Intermediate-Grade Non-Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of ICE Chemotherapy Followed by High Dose BEAM Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients 60 Years Old With Refractory or Relapsed Intermediate Grade Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-07
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 cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with peripheral stem cell transplantation works in treating older patients with refractory or relapsed intermediate-grade non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with peripheral stem cell transplantation works in treating older patients with refractory or relapsed intermediate-grade non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Assess the efficacy and toxic effects of carmustineetoposidemelphalan ICE chemotherapy followed by peripheral blood progenitor cell transplantation in patients with refractory or relapsed intermediate grade non-Hodgkins lymphoma
Assess the ability of the ICE chemotherapy regimen in conjunction with filgrastim to mobilize peripheral blood stem cells
OUTLINE This is a descriptive pilot study
Patients receive 3 cycles of induction chemotherapy with ifosfamide carboplatin and etoposide ICE Each cycle is given at least 14 days apart Patients receive etoposide IV on days 1 through 3 Carboplatin and ifosfamide with mercaptoethane sulfonate is given IV over 24 hours on day 2
During cycles 1 and 2 patients receive filgrastim G-CSF SC every 6 hours beginning on day 1 and continuing until the desired absolute neutrophil count ANC is attained
Patients receive at least 24 hours of rest before PBPC infusion on day 0
Following cycle 3 G-CSF is given SC beginning on day 6 and continuing until completion of PBPC collection However bone marrow will be harvested if an insufficient number of stem cells are collected after 5 leukaphereses
Patients with residual disease limited to 2 sites receive radiation therapy twice a day within 2 weeks prior to high dose BEAM chemotherapy with carmustine etoposide cytarabine and melphalan
Patients receive carmustine IV on day -7 Etoposide and cytarabine are given IV every 12 hours on days -6 through -3 Melphalan is given IV on day -2
G-CSF is administered every 12 hours beginning on day 1 and continuing until the desired ANC is attained If ANC is attenuated on day 21 patients undergo a repeat bone marrow biopsy and receive filgrastim SC
Patients are followed for 2 years posttransplant then for 3 to 5 years at 4 month intervals and every 6 months following the fifth posttransplant
PROJECTED ACCRUAL This study will accrue 30 patients for the duration of 2 years
Assess the efficacy and toxic effects of carmustineetoposidemelphalan ICE chemotherapy followed by peripheral blood progenitor cell transplantation in patients with refractory or relapsed intermediate grade non-Hodgkins lymphoma
Assess the ability of the ICE chemotherapy regimen in conjunction with filgrastim to mobilize peripheral blood stem cells
OUTLINE This is a descriptive pilot study
Patients receive 3 cycles of induction chemotherapy with ifosfamide carboplatin and etoposide ICE Each cycle is given at least 14 days apart Patients receive etoposide IV on days 1 through 3 Carboplatin and ifosfamide with mercaptoethane sulfonate is given IV over 24 hours on day 2
During cycles 1 and 2 patients receive filgrastim G-CSF SC every 6 hours beginning on day 1 and continuing until the desired absolute neutrophil count ANC is attained
Patients receive at least 24 hours of rest before PBPC infusion on day 0
Following cycle 3 G-CSF is given SC beginning on day 6 and continuing until completion of PBPC collection However bone marrow will be harvested if an insufficient number of stem cells are collected after 5 leukaphereses
Patients with residual disease limited to 2 sites receive radiation therapy twice a day within 2 weeks prior to high dose BEAM chemotherapy with carmustine etoposide cytarabine and melphalan
Patients receive carmustine IV on day -7 Etoposide and cytarabine are given IV every 12 hours on days -6 through -3 Melphalan is given IV on day -2
G-CSF is administered every 12 hours beginning on day 1 and continuing until the desired ANC is attained If ANC is attenuated on day 21 patients undergo a repeat bone marrow biopsy and receive filgrastim SC
Patients are followed for 2 years posttransplant then for 3 to 5 years at 4 month intervals and every 6 months following the fifth posttransplant
PROJECTED ACCRUAL This study will accrue 30 patients for the duration of 2 years
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-H97-1233 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065505 | REGISTRY | None | None |