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NCT01081808 · ClinicalTrials.gov registry record · Phase 1

Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and Sargramostim (GM-CSF) in Treating Advanced Solid Tumors

A Phase 1 study, sponsored by Roger Williams Medical Center.

Terminated
Registry status
Phase 1
Development phase
2
Enrollment target

NCT01081808: Clinical Trial Phase 1 study, sponsored by Roger Williams Medical Center.

NCT01081808 is a Phase 1 study that was terminated before completion, run by Roger Williams Medical Center. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01081808, a Phase 1 study, was terminated before completion, sponsored by Roger Williams Medical Center.

TERMINATED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients with recurrent, refractory, or metastatic advanced solid tumors.

Interventions

  • BIOLOGICAL EGFRBi-armed autologous activated T cells

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2009-10
Est. Completion 2015-02
Phase Phase 1
Roger Williams Medical Center

10 total trials

Why NCT01081808 stopped before completion

NCT01081808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which EGFRBi-armed autologous activated T cells is the first listed.

NCT01081808 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01081808 about?

NCT01081808 is a clinical study titled "Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and Sargramostim (GM-CSF) in Treating Advanced Solid Tumors". RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells fo...

What is the current status of trial NCT01081808?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2009-10. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01081808?

The interventions under investigation include: EGFRBi-armed autologous activated T cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT01081808?

This trial is sponsored by Roger Williams Medical Center, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01081808's enrollment target sits among peer trials

2 2000th of 2000 the lowest 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 NCT01081808, the US trial registry maintained by the National Library of Medicine. NCT01081808 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.