Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00006234 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : December 1, 2011
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | September 11, 2000 | |||
First Posted Date ICMJE | January 27, 2003 | |||
Last Update Posted Date | December 1, 2011 | |||
Study Start Date ICMJE | November 2001 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone | |||
Official Title ICMJE | A Phase I/II Study of 166Ho-DOTMP With Peripheral Blood Progenitor Cell Support for Refractory or Recurrent Ewing's Sarcoma Family of Tumors With Bone Disease | |||
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 I/II trial is studying the effectiveness of holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients who have metastatic Ewing's sarcoma or rhabdomyosarcoma that has spread to the bone. |
|||
Detailed Description | OBJECTIVES:
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
|||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | March 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00006234 | |||
Other Study ID Numbers ICMJE | 1474.00 FHCRC-1474.00 CHMC-S-6007 NCI-G00-1842 CDR0000068159 ( Registry Identifier: PDQ ) |
|||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Not Provided | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Fred Hutchinson Cancer Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
|
|||
PRS Account | Fred Hutchinson Cancer Center | |||
Verification Date | November 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |