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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: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

WHO (World Health Organization) tumor measurement criteria used to determine response.

Interventions

  • DRUG ifosfamide
  • PROCEDURE peripheral blood stem cell transplantation
  • BIOLOGICAL filgrastim
  • RADIATION Sm-EDTMP (low dose)
  • RADIATION sm-EDTMP (higher dose)

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2004-10
Est. Completion 2009-03
Phase Phase 2

What the finished NCT00245011 record still lists

NCT00245011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 5 interventions - of which ifosfamide is the first listed.

NCT00245011 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00245011's enrollment target sits among peer trials

11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00245011, the US trial registry maintained by the National Library of Medicine. NCT00245011 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.