Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002481
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
St Lukes Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of High-Dose Cytarabine Cisplatin and Dexamethasone Followed By Cyclophosphamide Etoposide Total Body Irradiation and Autologous Bone Marrow Rescue in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2001-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Bone marrow transplantation may allow doctors to give higher doses of radiation therapy and chemotherapy and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of high-dose etoposide and cyclophosphamide plus total-body irradiation followed by bone marrow transplantation in treating patients who have relapsed or refractory non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of high-dose etoposide and cyclophosphamide plus total-body irradiation followed by bone marrow transplantation in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the toxicity and activity of cyclophosphamide etoposide total body irradiation and autologous bone marrow transplantation in patients with relapsed or refractory non-Hodgkins lymphoma II Determine the feasibility of pretransplantation cytoreduction with a regimen of high-dose cytarabine cisplatin and dexamethasone in this patient population III Determine the feasibility of posttransplantation radiotherapy given to sites of residual disease involved-field boost irradiation in this patient population
OUTLINE Patients are stratified by disease status refractory vs relapsed Autologous bone marrow is harvested before cytoreduction or involved field radiotherapy IFRT Patients with marrow involvement who achieve marrow complete response after cytoreduction undergo harvest of bone marrow before IFRT Patients receive cytoreduction comprising high-dose cytarabine IV over 1 hour every 12 hours cisplatin IV over 10 hours and dexamethasone three times daily on days 1 and 2 At 3 weeks a second course is administered if tumor reduction is at least 25 and in the absence of unacceptable toxicity Patients with involved sites 2 cm or greater in diameter at evaluation and previously unirradiated active disease sites at least 90 of which can be treated with IFRT undergo IFRT 5 days a week for 2 weeks beginning after cytoreduction and 3-5 weeks after harvest of bone marrow Within 10 days after completion of IFRT patients receive etoposide IV over 26 hours beginning on day -7 cyclophosphamide IV over 2 hours on days -6 to -4 and total body irradiation twice daily on days -3 and -2 and once on day -1 Bone marrow is reinfused on day 0 Eligible patients with residual disease at 3 months after transplantation undergo involved field boost irradiation to sites of residual disease
PROJECTED ACCRUAL Approximately 50 patients 25 per stratum will be accrued for this study
OUTLINE Patients are stratified by disease status refractory vs relapsed Autologous bone marrow is harvested before cytoreduction or involved field radiotherapy IFRT Patients with marrow involvement who achieve marrow complete response after cytoreduction undergo harvest of bone marrow before IFRT Patients receive cytoreduction comprising high-dose cytarabine IV over 1 hour every 12 hours cisplatin IV over 10 hours and dexamethasone three times daily on days 1 and 2 At 3 weeks a second course is administered if tumor reduction is at least 25 and in the absence of unacceptable toxicity Patients with involved sites 2 cm or greater in diameter at evaluation and previously unirradiated active disease sites at least 90 of which can be treated with IFRT undergo IFRT 5 days a week for 2 weeks beginning after cytoreduction and 3-5 weeks after harvest of bone marrow Within 10 days after completion of IFRT patients receive etoposide IV over 26 hours beginning on day -7 cyclophosphamide IV over 2 hours on days -6 to -4 and total body irradiation twice daily on days -3 and -2 and once on day -1 Bone marrow is reinfused on day 0 Eligible patients with residual disease at 3 months after transplantation undergo involved field boost irradiation to sites of residual disease
PROJECTED ACCRUAL Approximately 50 patients 25 per stratum will be accrued for this study
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-V91-0112 | None | None | None |
| STLMC-ABMR-9001 | None | None | None |