Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004898
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2000-03-07
Brief Title:
Radiation Therapy and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With High-Grade Lymphoma or Acute Lymphoblastic Leukemia
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Dose Escalation of VP-16 With Cyclophosphamide and Total Body Irradiation as Preparative Regimen for Autologous Transplantation for High-Grade Lymphoma and Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2012-06
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 Radiation therapy uses high-energy x-rays to damage cancer cells 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 Phase III trial to study the effectiveness of radiation therapy and chemotherapy plus peripheral stem cell transplantation in treating patients who have high-grade lymphoma or acute lymphoblastic leukemia
PURPOSE Phase III trial to study the effectiveness of radiation therapy and chemotherapy plus peripheral stem cell transplantation in treating patients who have high-grade lymphoma or acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES I Determine the toxicity of an intensive induction regimen comprised of etoposide with cyclophosphamide and total body irradiation TBI in patients with high grade lymphoma or acute lymphoblastic leukemia ALL II Determine the maximum tolerated dose of etoposide when combined with cyclophosphamide and TBI in these patients III Determine the response rate in patients treated with this induction regimen IV Determine the potential for long term survival in patients with relapsed lymphoblastic lymphoma and chemotherapy responsiveness treated with this induction regimen V Determine the efficacy of this induction regimen followed by autologous peripheral blood stem cell transplantation APBSCT in patients with ALL in any complete remission VI Determine the efficacy of this induction regimen followed by APBSCT in patients will ALL after relapse and remission reinduction
OUTLINE This is a dose escalation study of etoposide Patients undergo total body irradiation twice daily on days -8 to -5 Patients receive etoposide IV over 30 hours beginning on day -5 and cyclophosphamide IV over 1 hour on day -3 beginning 6 hours after completion of etoposide infusion and day -2 Peripheral blood stem cells are reinfused on day 0 Patients receive filgrastim G-CSF subcutaneously daily beginning on day 0 and continuing until blood counts have recovered for 2 days Cohorts of 5 patients receive escalating doses of etoposide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 5 patients experience dose limiting toxicity Patients are followed every month for 1 year and then every 6 months for 25 years
PROJECTED ACCRUAL A minimum of 5 patients will be accrued for this study
OUTLINE This is a dose escalation study of etoposide Patients undergo total body irradiation twice daily on days -8 to -5 Patients receive etoposide IV over 30 hours beginning on day -5 and cyclophosphamide IV over 1 hour on day -3 beginning 6 hours after completion of etoposide infusion and day -2 Peripheral blood stem cells are reinfused on day 0 Patients receive filgrastim G-CSF subcutaneously daily beginning on day 0 and continuing until blood counts have recovered for 2 days Cohorts of 5 patients receive escalating doses of etoposide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 5 patients experience dose limiting toxicity Patients are followed every month for 1 year and then every 6 months for 25 years
PROJECTED ACCRUAL A minimum of 5 patients 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-G00-1687 | None | None | None |
| NU-91H5I | None | None | None |