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NCT00001440 · ClinicalTrials.gov registry record · Phase 1

Autologous T-Cell Transplantation and the Immunotherapy of Residual Disease in Breast Cancer: Pilot Study of Vaccine-Driven T-Cell Expansion in Patients Treated With Dose-Intensive Chemotherapy

A Phase 1 study of Neoplasm Metastasis and Breast Neoplasm, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
51
Enrollment target
1
Study location

NCT00001440 is a Phase 1 study of Neoplasm Metastasis and Breast Neoplasm that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 51 participants, below the 415-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001440, a Phase 1 study of Neoplasm Metastasis and Breast Neoplasm, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
51 participants
Enrollment target
1
Study location

Study Summary

The ability of chemotherapy to cure cancer, including breast cancer, has been limited by drug resistant residual tumor cells remaining after chemotherapy that generally result in relapse. Additional therapeutic strategies to eradicate these residual tumor cells are needed. The augmentation of specific anti-tumor immune responses, such as those mediated by T-cells, might represent such an additional strategy for the control or elimination of residual tumor cells. This approach might be especially effective if T-cell mediated responses were enhanced during both the period of T-cell repopulation that follows acute T-cell depletion and in the setting of minimal residual tumor burden present after dose intensive chemotherapy. Such chemotherapy is known to result in severe T-cell depletion. This pilot study has been designed to examine the feasibility of combining dose intensive chemotherapy with interventions aimed at the reconstitution of T-cell immunity. Metastatic or adjuvant breast cancer patients who have received dose intensive chemotherapy will subsequently receive a combination of autologous chemotherapy-naive T-cells, a patient-specific tumor antigen vaccine, and recombinant human interleukin-2. These interventions will be assessed for their ability to modulate T-cell number, T-cell function, and T-cell specificity during the period of T-cell repopulation. Such modulation may result in the effective reconstitution of generalized T-cell immunity with the generation of vaccine-specific anti-tumor T-cell responses.

Interventions

  • DRUG Interleukin-2
  • PROCEDURE Autologous T cells

Study Locations (1)

Maryland

  • National Cancer Institute (NCI) - Bethesda

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 1995-07
Est. Completion 2002-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00001440

The ClinicalTrials.gov registry entry for NCT00001440 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 415-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (88% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Neoplasm Metastasis appearing as the primary indexed condition, and to 2 interventions - of which Interleukin-2 is the first listed.

NCT00001440 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001440 about?

NCT00001440 is a clinical study titled "Autologous T-Cell Transplantation and the Immunotherapy of Residual Disease in Breast Cancer: Pilot Study of Vaccine-Driven T-Cell Expansion in Patients Treated With Dose-Intensive Chemotherapy". The ability of chemotherapy to cure cancer, including breast cancer, has been limited by drug resistant residual tumor cells remaining after chemotherapy that generally result in relapse. Additional therapeutic strategies to eradicate these residual tumor cells are needed. The augmentation of specif...

What is the current status of trial NCT00001440?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 1995-07. Estimated completion is 2002-01.

What conditions does trial NCT00001440 study?

This clinical trial studies the following conditions: Neoplasm Metastasis, Breast Neoplasm.

What interventions are being tested in trial NCT00001440?

The interventions under investigation include: Interleukin-2 (DRUG), Autologous T cells (PROCEDURE).

Who is sponsoring clinical trial NCT00001440?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001440 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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