Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003081
Status:
COMPLETED
Last Update Posted:
2010-09-20
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Peripheral Stem Cell Transplantation and Radiation Therapy in Treating Patients With Ewings Sarcoma Peripheral Primitive Neuroectodermal Tumor or Rhabdomyosarcoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase I Trial of Busulfan Thiotepa and Melphalan Followed by Autologous or Syngeneic Peripheral Blood Stem Cell Transplantation and Followed by Total Marrow Skeletal Irradiation TMI in Patients With High-Risk Ewings Sarcoma PNET or Rhabdomyosarcoma
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 tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy peripheral stem cell transplantation and radiation therapy in treating patients with recurrent metastatic Ewings sarcoma peripheral primitive neuroectodermal tumor or rhabdomyosarcoma
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy peripheral stem cell transplantation and radiation therapy in treating patients with recurrent metastatic Ewings sarcoma peripheral primitive neuroectodermal tumor or rhabdomyosarcoma
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose of total bone marrow irradiation TMI that can be administered as planned consolidation utilizing autologous peripheral blood stem cell support following local radiotherapy if indicated and prior busulfan melphalan and thiotepa II Examine the efficacy of this dual transplant approach for high-risk patients with Ewings sarcoma peripheral primitive neuroectodermal tumor or rhabdomyosarcoma in first complete remission or greater
OUTLINE This is a two part radiation dose escalation study Peripheral blood stem cells PBSC are collected after 5-6 daily injections of G-CSF The PBSC are infused in two halves One half is given after chemotherapy and the other half after total marrow irradiation TMI Transplant 1 part one consists of chemotherapy and PBSC infusion Busulfan BU is administered orally every 6 hours for 3 days for a total of 12 doses on days -8 -7 and -6 Melphalan is intravenously infused over 30 minutes for 2 days on days -5 and -4 Thiotepa is intravenously infused over 2 hours on days -3 and -2 PBSC are infused on day 0 36-48 hours after completion of chemotherapy Patients are considered for local irradiation therapy between transplant 1 and 2 if tissue limiting irradiation doses to bulk tumor site have not previously been administered The local irradiation is given immediately prior to TMI administration Transplant 2 starts sometime between day 60 and 120 after transplant 1 For transplant 2 cohorts of 4 patients are treated with TMI twice a day for 5 days at initial dose level on days -5 through -1 TMI is administered over 30-40 minutes The second half of the PBSC is infused 1-24 hours following the last dose of TMI After treatment of at least 4 patients at the initial TMI dose level dose levels escalate in the absence of toxicity If there is no dose limiting toxicity DLT in the current group of 4 patients the next cohort is treated at the next higher dose level If 1 of the 4 patients experiences DLT the next cohort is treated at the same dose If 1 DLT is seen among 8 patients treated at a dose then the next cohort is treated at the next higher dose level If 2 patients out of 8 experience DLT this dose is identified as the maximum tolerated dose MTD If 1 out of 4 or 3 out 8 patients experience DLT at a dose level the next lower dose level is identified as the MTD Each patient in a cohort is observed for a minimum of 28 days prior to escalation to the higher dose level Tumor restaging occurs approximately 9 months after initial transplant then at 12 months and annually thereafter
PROJECTED ACCRUAL An expected 12-16 patients are required to complete this study Accrual should last 3-4 years at 4-5 patients per year
OUTLINE This is a two part radiation dose escalation study Peripheral blood stem cells PBSC are collected after 5-6 daily injections of G-CSF The PBSC are infused in two halves One half is given after chemotherapy and the other half after total marrow irradiation TMI Transplant 1 part one consists of chemotherapy and PBSC infusion Busulfan BU is administered orally every 6 hours for 3 days for a total of 12 doses on days -8 -7 and -6 Melphalan is intravenously infused over 30 minutes for 2 days on days -5 and -4 Thiotepa is intravenously infused over 2 hours on days -3 and -2 PBSC are infused on day 0 36-48 hours after completion of chemotherapy Patients are considered for local irradiation therapy between transplant 1 and 2 if tissue limiting irradiation doses to bulk tumor site have not previously been administered The local irradiation is given immediately prior to TMI administration Transplant 2 starts sometime between day 60 and 120 after transplant 1 For transplant 2 cohorts of 4 patients are treated with TMI twice a day for 5 days at initial dose level on days -5 through -1 TMI is administered over 30-40 minutes The second half of the PBSC is infused 1-24 hours following the last dose of TMI After treatment of at least 4 patients at the initial TMI dose level dose levels escalate in the absence of toxicity If there is no dose limiting toxicity DLT in the current group of 4 patients the next cohort is treated at the next higher dose level If 1 of the 4 patients experiences DLT the next cohort is treated at the same dose If 1 DLT is seen among 8 patients treated at a dose then the next cohort is treated at the next higher dose level If 2 patients out of 8 experience DLT this dose is identified as the maximum tolerated dose MTD If 1 out of 4 or 3 out 8 patients experience DLT at a dose level the next lower dose level is identified as the MTD Each patient in a cohort is observed for a minimum of 28 days prior to escalation to the higher dose level Tumor restaging occurs approximately 9 months after initial transplant then at 12 months and annually thereafter
PROJECTED ACCRUAL An expected 12-16 patients are required to complete this study Accrual should last 3-4 years at 4-5 patients per year
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 |
|---|---|---|---|
| CDR0000065777 | None | None | None |
| NCI-G97-1331 | None | None | None |