Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002510
Status:
COMPLETED
Last Update Posted:
2010-10-01
First Post:
1999-11-01
Brief Title:
Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
HIGH-DOSE CHEMORADIOTHERAPY FOLLOWED BY RESCUE WITH MOBILIZED AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH LOW-GRADE TRANSFORMED OR FOLLICULAR LARGE CELL NON-HODGKINS LYMPHOMA
Status:
COMPLETED
Status Verified Date:
2010-09
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 Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and radiation therapy and kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of etoposide plus radiation therapy followed by peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma
PURPOSE Phase III trial to study the effectiveness of etoposide plus radiation therapy followed by peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Evaluate the overall and progression-free survival of patients with selected poor-prognosis non-Hodgkins lymphomas treated with high-dose etoposide and total-body irradiation followed by rescue with peripheral blood stem cells II Determine the toxicity of this regimen III Evaluate the short-term and long-term engraftment characteristics of patients treated on this regimen
OUTLINE Patients who respond on Regimen A and who have no bulk disease greater than 5 cm are treated on Regimen B Regimen A Single-Agent ChemotherapyStem Cell Mobilization with Urothelial Protection and Growth Factor Therapy Cyclophosphamide CTX NSC-26271 with Mesna NSC-113891 and Granulocyte Colony Stimulating Factor Amgen G-CSF NSC-614629 Regimen B Sequential Radiotherapy Single-Agent Chemotherapy and Stem Cell Rescue Total-body irradiation TBI equipment not specified Etoposide VP-16 NSC-141540 and Peripheral Blood Stem Cells PBSC
PROJECTED ACCRUAL 20 patients will be studied
OUTLINE Patients who respond on Regimen A and who have no bulk disease greater than 5 cm are treated on Regimen B Regimen A Single-Agent ChemotherapyStem Cell Mobilization with Urothelial Protection and Growth Factor Therapy Cyclophosphamide CTX NSC-26271 with Mesna NSC-113891 and Granulocyte Colony Stimulating Factor Amgen G-CSF NSC-614629 Regimen B Sequential Radiotherapy Single-Agent Chemotherapy and Stem Cell Rescue Total-body irradiation TBI equipment not specified Etoposide VP-16 NSC-141540 and Peripheral Blood Stem Cells PBSC
PROJECTED ACCRUAL 20 patients will be studied
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-V92-0206 | None | None | None |
| TUHSC-2049 | None | None | None |