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NCT00245011 · ClinicalTrials.gov registry record · Phase 2
Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00245011 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 11 participants.
The verdict
NCT00245011, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
Interventions
- DRUG ifosfamide
- PROCEDURE peripheral blood stem cell transplantation
- BIOLOGICAL filgrastim
- RADIATION Sm-EDTMP (low dose)
- RADIATION sm-EDTMP (higher dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2004-10 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00245011
The ClinicalTrials.gov registry entry for NCT00245011 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which ifosfamide is the first listed.
NCT00245011 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00245011 about?
NCT00245011 is a clinical study titled "Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma". RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentaso...
What is the current status of trial NCT00245011?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2004-10. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00245011?
The interventions under investigation include: ifosfamide (DRUG), peripheral blood stem cell transplantation (PROCEDURE), filgrastim (BIOLOGICAL), Sm-EDTMP (low dose) (RADIATION), sm-EDTMP (higher dose) (RADIATION).
Who is sponsoring clinical trial NCT00245011?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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