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NCT00001880 · ClinicalTrials.gov registry record · Phase 2

Stem Cell Transplantation for Metastatic Solid Tumors

A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Terminated
Registry status
Phase 2
Development phase
42
Enrollment target

NCT00001880: Clinical Trial Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

NCT00001880 is a Phase 2 study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001880, a Phase 2 study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

TERMINATED
Registry status
Phase 2
Development phase
42 participants
Enrollment target

Study Summary

The goal of this research study is to identify other types of cancer (malignant neoplasms) that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell transplantation. Patients with a variety of different types of cancerous tumors that have spread (metastasized) and whose conditions have not improved with stand therapy, will be eligible to participate. Those patients selected to participate in the study will undergo a procedure known as a "mini-transplant". The mini-transplant is a transplantation of stem-cells collected from a sibling (brother or sister) of the patient. Unlike traditional bone marrow transplants, the mini-transplant does not require intense chemotherapy or radiation therapy. Because of this, patients experience fewer and less severe side effects. This study is open to patients diagnosed with a variety of metastatic solid tumors including esophageal, gastric (stomach), colon, rectal, liver tumors (hepatoma), cancer of the biliary system (cholangiocarcinoma), cancer of the pancreas, lung, breast, prostate, bone (sarcoma), adrenal basal cell, bladder, and adenocarcinomas of unk primary origin.

Primary Outcome

To identify an anti-tumor effect of allogenic PNSC transplantation by induction of a graft-versus-tumor (GVT) effect in patients with a diversity of metastatic solid tumors, which are refractory to standard therapy. Tumor response assessed as follows: Complete response (CR): disappearance of all signs and symptoms of metastatic disease for a period of at least one month. Partial response (PR): a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all m

Interventions

  • DRUG methotrexate
  • DRUG Cyclosporin

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 1999-03-12
Est. Completion 2020-08-13
Phase Phase 2

Why NCT00001880 stopped before completion

NCT00001880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which methotrexate is the first listed.

NCT00001880 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001880 about?

NCT00001880 is a clinical study titled "Stem Cell Transplantation for Metastatic Solid Tumors". The goal of this research study is to identify other types of cancer (malignant neoplasms) that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell transplantation. Patients with a variety of different types of cancerous tumors that have spread (metastasized) and w...

What is the current status of trial NCT00001880?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 1999-03-12. Estimated completion is 2020-08-13.

What interventions are being tested in trial NCT00001880?

The interventions under investigation include: methotrexate (DRUG), Cyclosporin (DRUG).

Who is sponsoring clinical trial NCT00001880?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001880's enrollment target sits among peer trials

42 1339th of 2000 higher than 649 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 NCT00001880, the US trial registry maintained by the National Library of Medicine. NCT00001880 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.