Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003541
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Radiation Therapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
High Dose Combined Modality Therapy With Peripheral Blood Progenitor Cell Transplantation as Primary Treatment for Patients With Mantle Cell Lymphoma
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 cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Combining chemotherapy radiation therapy and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy radiation therapy and peripheral stem cell transplantation in treating patients who have stage III or stage IV mantle cell lymphoma
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy radiation therapy and peripheral stem cell transplantation in treating patients who have stage III or stage IV mantle cell lymphoma
Detailed Description:
OBJECTIVES I Evaluate the response to a 8 week induction chemotherapy program consisting of cyclophosphamide doxorubicin vincristine and prednisone CHOP in patients with mantle cell lymphoma II Evaluate the efficacy of ifosfamide carboplatin and etoposide ICE chemotherapy and filgrastim G-CSF for peripheral blood stem cell PBSC mobilization in this patient population III Evaluate the safety and efficacy of ICE followed by total body irradiation and high dose cyclophosphamide and etoposide in this patient population IV Assess the contamination of PBSCs by lymphoma cells following mobilization by chemotherapy and G-CSF in this patient population
OUTLINE Patients receive induction chemotherapy with cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 oral prednisone daily on days 2-6 and filgrastim G-CSF subcutaneously daily on days 6-10 Treatment is repeated every 14 days for up to 4 courses Patients receive consolidation chemotherapy with ifosfamide IV over 24 hours and carboplatin IV on day 2 etoposide IV daily on days 1-3 and G-CSF subcutaneously on days 5-12 for course 1 and on day 5 for course 2 and continuing through peripheral blood stem cell PBSC collection Treatment is repeated every 14 days for 2 courses Following PBSC collection patients receive total body irradiation twice a day for 4 days plus etoposide IV over 72 hours on days -6 -5 and -4 and cyclophosphamide IV daily on days -3 and -2 PBSCs are infused on day 0 Patients receive G-CSF IV or subcutaneously twice a day beginning on day 1 Patients are followed every 3 months for 2 years every 6 months for 3 years and annually thereafter
PROJECTED ACCRUAL Approximately 14-24 patients will be accrued for this study within two years
OUTLINE Patients receive induction chemotherapy with cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 oral prednisone daily on days 2-6 and filgrastim G-CSF subcutaneously daily on days 6-10 Treatment is repeated every 14 days for up to 4 courses Patients receive consolidation chemotherapy with ifosfamide IV over 24 hours and carboplatin IV on day 2 etoposide IV daily on days 1-3 and G-CSF subcutaneously on days 5-12 for course 1 and on day 5 for course 2 and continuing through peripheral blood stem cell PBSC collection Treatment is repeated every 14 days for 2 courses Following PBSC collection patients receive total body irradiation twice a day for 4 days plus etoposide IV over 72 hours on days -6 -5 and -4 and cyclophosphamide IV daily on days -3 and -2 PBSCs are infused on day 0 Patients receive G-CSF IV or subcutaneously twice a day beginning on day 1 Patients are followed every 3 months for 2 years every 6 months for 3 years and annually thereafter
PROJECTED ACCRUAL Approximately 14-24 patients will be accrued for this study within two 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 |
|---|---|---|---|
| CDR0000066595 | REGISTRY | None | None |
| NCI-H98-0021 | Registry Identifier | PDQ Physician Data Query | None |