Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006234
Status:
COMPLETED
Last Update Posted:
2011-12-01
First Post:
2000-09-11
Brief Title:
Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewings Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Study of 166Ho-DOTMP With Peripheral Blood Progenitor Cell Support for Refractory or Recurrent Ewings Sarcoma Family of Tumors With Bone Disease
Status:
COMPLETED
Status Verified Date:
2011-11
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 Radioactive drugs such as holmium Ho 166 DOTMP may carry radiation directly to cancer cells and not harm normal cells Peripheral stem cell transplantation may be able to replace stem cells that were destroyed by the radioactive drug
PURPOSE This Phase III trial is studying the effectiveness of holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients who have metastatic Ewings sarcoma or rhabdomyosarcoma that has spread to the bone
PURPOSE This Phase III trial is studying the effectiveness of holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients who have metastatic Ewings sarcoma or rhabdomyosarcoma that has spread to the bone
Detailed Description:
OBJECTIVES
Determine the dosimetry of holmium Ho 166 DOTMP in patients with metastatic Ewings sarcoma family of tumors or rhabdomyosarcoma with bone metastases
Provide treatment with holmium Ho 166 DOTMP for these patients
Determine the toxicity and pharmacokinetics of this drug in these patients
Determine the change in tumor cell content in peripheral blood and bone marrow after treatment with this drug in these patients
OUTLINE Patients receive a trace dose of holmium Ho 166 DOTMP IV over 10 minutes on day -7 and an assigned dose over 10 minutes on day 0 Autologous peripheral blood stem cells are infused on days 7-10
Patients are followed at least weekly for 4 weeks and then monthly for 1 year or until disease progression
PROJECTED ACCRUAL A total of 4 patients will be accrued for this study
Determine the dosimetry of holmium Ho 166 DOTMP in patients with metastatic Ewings sarcoma family of tumors or rhabdomyosarcoma with bone metastases
Provide treatment with holmium Ho 166 DOTMP for these patients
Determine the toxicity and pharmacokinetics of this drug in these patients
Determine the change in tumor cell content in peripheral blood and bone marrow after treatment with this drug in these patients
OUTLINE Patients receive a trace dose of holmium Ho 166 DOTMP IV over 10 minutes on day -7 and an assigned dose over 10 minutes on day 0 Autologous peripheral blood stem cells are infused on days 7-10
Patients are followed at least weekly for 4 weeks and then monthly for 1 year or until disease progression
PROJECTED ACCRUAL A total of 4 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 |
|---|---|---|---|
| CDR0000068159 | REGISTRY | PDQ | None |
| FHCRC-147400 | None | None | None |
| CHMC-S-6007 | None | None | None |
| NCI-G00-1842 | None | None | None |