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NCT00004085 · ClinicalTrials.gov registry record · Phase 1

Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer

A Phase 1 study, sponsored by Garden State Cancer Center at the Center for Molecular Medicine and Immunology.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT00004085: Completed Phase 1 study, sponsored by Garden State Cancer Center at the Center for Molecular Medicine and Immunology.

NCT00004085 is a Phase 1 study that has completed, run by Garden State Cancer Center at the Center for Molecular Medicine and Immunology. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004085, a Phase 1 study, has completed, sponsored by Garden State Cancer Center at the Center for Molecular Medicine and Immunology.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy used to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus peripheral stem cell transplantation in treating patients who have stage IV breast cancer.

Primary Outcome

maximum tolerated dose

Interventions

  • PROCEDURE peripheral blood stem cell transplantation
  • BIOLOGICAL filgrastim
  • PROCEDURE autologous bone marrow transplantation
  • RADIATION yttrium Y 90 monoclonal antibody MN-14

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 1998-05
Phase Phase 1

What the finished NCT00004085 record still lists

NCT00004085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 4 interventions - of which peripheral blood stem cell transplantation is the first listed.

NCT00004085 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004085 about?

NCT00004085 is a clinical study titled "Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer". RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy used to kill tumor cells. PURPOSE: Phase I/II trial to study the effe...

What is the current status of trial NCT00004085?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 1998-05.

What interventions are being tested in trial NCT00004085?

The interventions under investigation include: peripheral blood stem cell transplantation (PROCEDURE), filgrastim (BIOLOGICAL), autologous bone marrow transplantation (PROCEDURE), yttrium Y 90 monoclonal antibody MN-14 (RADIATION).

Who is sponsoring clinical trial NCT00004085?

This trial is sponsored by Garden State Cancer Center at the Center for Molecular Medicine and Immunology, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00004085's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00004085, the US trial registry maintained by the National Library of Medicine. NCT00004085 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.