Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060255
Status:
COMPLETED
Last Update Posted:
2013-05-09
First Post:
2003-05-06
Brief Title:
High-Dose Chemotherapy Total-Body Irradiation and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-05
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 Combining chemotherapy with autologous stem cell transplantation or autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors
PURPOSE This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors
Detailed Description:
OBJECTIVES
Determine the morbidity mortality and overall outcome in patients with hematologic malignancies breast cancer or other chemosensitive solid tumors treated with disease-specific dose-intensive conditioning regimens and autologous peripheral blood or bone marrow transplantation
OUTLINE Patients are stratified according to risk group standard vs high Standard risk includes acute leukemia in first relapse or second remission lymphoma in responding first relapse or second remission or breast cancer at risk for recurrence High risk includes all others Patients receive specific conditioning regimens according to diagnosis as outlined below
Conditioning
Regimen A standard risk non-Hodgkins lymphoma and under 60 years of age-Etoposide cyclophosphamide and total body irradiation TBI VCT Patients receive etoposide IV continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on day -4 Patients undergo TBI on days -3 to -1
Regimen B any risk Hodgkins lymphoma and under 60 years of age-Cyclophosphamide carmustine and etoposide CBV Patients receive etoposide IV continuously over 34 hours beginning on day -8 cyclophosphamide IV over 2 hours on days -7 to -4 and carmustine IV over 2 hours on day -3
Regimen C any risk patient with prior exposure to high-dose etoposide and cyclophosphamide and under 60 years of age-Melphalan and TBI MELTBI Patients receive melphalan IV over 30 minutes on day -4 Patients undergo TBI on days -3 to -1
Regimen D multiple myeloma or amyloidosis-Melphalan only MEL only Patients receive melphalan IV over 30 minutes on day -2
Regimen E any patient unable to receive TBI-Busulfan and cyclophosphamide Patients receive oral busulfan or busulfan IV over 2 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2
Regimen F any risk breast cancer-Cyclophosphamide carboplatin and thiotepa STAMP V Patients receive cyclophosphamide IV over 24 hours carboplatin IV over 24 hours and thiotepa IV over 24 hours on days -7 to -4
Regimen G solid tumors other than breast or testicular cancer-Thiotepa and carboplatin TTCARBO Patients receive thiotepa IV over 2 hours on days -6 and -5 and carboplatin IV continuously over 96 hours beginning on day -6
Regimen H recurrent or primary progressive testicular cancer-Etoposide and carboplatin VPCARBO Patients receive etoposide IV over 2 hours and carboplatin IV over 30 minutes on days -6 to -4
Stem Cell Infusion
In all regimens patients undergo autologous stem cell infusion on day 0 Treatment continues in the absence of unacceptable toxicity
PROJECTED ACCRUAL Approximately 450 patients 50 patients 25 per stratum per regimen will be accrued for this study within 10 years
Determine the morbidity mortality and overall outcome in patients with hematologic malignancies breast cancer or other chemosensitive solid tumors treated with disease-specific dose-intensive conditioning regimens and autologous peripheral blood or bone marrow transplantation
OUTLINE Patients are stratified according to risk group standard vs high Standard risk includes acute leukemia in first relapse or second remission lymphoma in responding first relapse or second remission or breast cancer at risk for recurrence High risk includes all others Patients receive specific conditioning regimens according to diagnosis as outlined below
Conditioning
Regimen A standard risk non-Hodgkins lymphoma and under 60 years of age-Etoposide cyclophosphamide and total body irradiation TBI VCT Patients receive etoposide IV continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on day -4 Patients undergo TBI on days -3 to -1
Regimen B any risk Hodgkins lymphoma and under 60 years of age-Cyclophosphamide carmustine and etoposide CBV Patients receive etoposide IV continuously over 34 hours beginning on day -8 cyclophosphamide IV over 2 hours on days -7 to -4 and carmustine IV over 2 hours on day -3
Regimen C any risk patient with prior exposure to high-dose etoposide and cyclophosphamide and under 60 years of age-Melphalan and TBI MELTBI Patients receive melphalan IV over 30 minutes on day -4 Patients undergo TBI on days -3 to -1
Regimen D multiple myeloma or amyloidosis-Melphalan only MEL only Patients receive melphalan IV over 30 minutes on day -2
Regimen E any patient unable to receive TBI-Busulfan and cyclophosphamide Patients receive oral busulfan or busulfan IV over 2 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2
Regimen F any risk breast cancer-Cyclophosphamide carboplatin and thiotepa STAMP V Patients receive cyclophosphamide IV over 24 hours carboplatin IV over 24 hours and thiotepa IV over 24 hours on days -7 to -4
Regimen G solid tumors other than breast or testicular cancer-Thiotepa and carboplatin TTCARBO Patients receive thiotepa IV over 2 hours on days -6 and -5 and carboplatin IV continuously over 96 hours beginning on day -6
Regimen H recurrent or primary progressive testicular cancer-Etoposide and carboplatin VPCARBO Patients receive etoposide IV over 2 hours and carboplatin IV over 30 minutes on days -6 to -4
Stem Cell Infusion
In all regimens patients undergo autologous stem cell infusion on day 0 Treatment continues in the absence of unacceptable toxicity
PROJECTED ACCRUAL Approximately 450 patients 50 patients 25 per stratum per regimen will be accrued for this study within 10 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 |
|---|---|---|---|
| RPCI-DS-9115 | None | None | None |