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NCT01417546 · ClinicalTrials.gov registry record · Phase 1

NHS-IL12 for Solid Tumors

A Phase 1 study of Epithelial Neoplasms, Malignant and Epithelial Tumors, Malignant, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
72
Enrollment target
1
Study location

NCT01417546 is a Phase 1 study of Epithelial Neoplasms, Malignant and Epithelial Tumors, Malignant that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 72 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT01417546, a Phase 1 study of Epithelial Neoplasms, Malignant and Epithelial Tumors, Malignant, has completed, sponsored by National Cancer Institute (NCI).

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

Study Summary

Background: \- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is needed to test NHS-IL12 in people who have solid tumors that have not responded to treatment. Objectives: \- To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age with solid tumors that have not responded to standard treatments. Design: * Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies. * Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the hospital for at least one day to be monitored with frequent blood tests. * Participants will have periodic blood samples taken before treatment and during the first week after treatment for the first two cycles. They will then have blood samples taken before treatment for the rest of the cycles.

Interventions

  • DRUG NHS-IL-12

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2011-12-12
Est. Completion 2021-10-14
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01417546

The ClinicalTrials.gov registry entry for NCT01417546 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Epithelial Neoplasms, Malignant appearing as the primary indexed condition, and to 1 intervention - of which NHS-IL-12 is the first listed.

NCT01417546 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01417546 about?

NCT01417546 is a clinical study titled "NHS-IL12 for Solid Tumors". Background: \- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is nee...

What is the current status of trial NCT01417546?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2011-12-12. Estimated completion is 2021-10-14.

What conditions does trial NCT01417546 study?

This clinical trial studies the following conditions: Epithelial Neoplasms, Malignant, Epithelial Tumors, Malignant, Malignant Mesenchymal Tumor.

What interventions are being tested in trial NCT01417546?

The interventions under investigation include: NHS-IL-12 (DRUG).

Who is sponsoring clinical trial NCT01417546?

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

Where is trial NCT01417546 being conducted?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.