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NCT00853125 · ClinicalTrials.gov registry record · Phase 2

Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

A Phase 2 study, sponsored by Rutgers, The State University of New Jersey.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT00853125: Clinical Trial Phase 2 study, sponsored by Rutgers, The State University of New Jersey.

NCT00853125 is a Phase 2 study that was terminated before completion, run by Rutgers, The State University of New Jersey. The registered enrollment target is 10 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

NCT00853125, a Phase 2 study, was terminated before completion, sponsored by Rutgers, The State University of New Jersey.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving sunitinib together with irradiated donor lymphocytes may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sunitinib together with irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.

Primary Outcome

Determined as the time from treatment with combination sunitinib with irradiated allogeneic lymphocytes to progressive disease or death whichever occurred first. Progression is determined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Interventions

  • DRUG sunitinib malate
  • BIOLOGICAL therapeutic allogeneic lymphocytes

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2009-02
Est. Completion 2014-02-22
Phase Phase 2

Why NCT00853125 stopped before completion

NCT00853125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 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 2 interventions - of which sunitinib malate is the first listed.

NCT00853125 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00853125 about?

NCT00853125 is a clinical study titled "Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer". RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving sunitinib together with irradia...

What is the current status of trial NCT00853125?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2009-02. Estimated completion is 2014-02-22.

What interventions are being tested in trial NCT00853125?

The interventions under investigation include: sunitinib malate (DRUG), therapeutic allogeneic lymphocytes (BIOLOGICAL).

Who is sponsoring clinical trial NCT00853125?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00853125's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 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 NCT00853125, the US trial registry maintained by the National Library of Medicine. NCT00853125 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.