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NCT01307618 · ClinicalTrials.gov registry record · Phase 2

Vaccine Therapy With or Without Recombinant Interleukin-12 Followed by Daclizumab in Treating Patients With Metastatic Melanoma

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT01307618: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01307618 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01307618, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

This randomized phase II trial is studying how well giving vaccine therapy together with or without recombinant interleukin-12 followed by daclizumab works in treating patients with melanoma that has spread to other places in the body. Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells. Recombinant interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells. Monoclonal antibodies, such as daclizumab, may decrease the number of regulatory T cells (T cells that suppress the activation of the immmune system) and may lead to a better immune response against melanoma. It is not yet known whether vaccine therapy is more effective with interleukin-12 and daclizumab in treating melanoma.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Recombinant Interleukin-12
  • BIOLOGICAL MART-1 Antigen
  • BIOLOGICAL NA17.A2 Peptide Vaccine
  • BIOLOGICAL Recombinant MAGE-3.1 Antigen

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2011-02
Est. Completion 2015-02
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01307618

The ClinicalTrials.gov registry entry for NCT01307618 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 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 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01307618 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01307618 about?

NCT01307618 is a clinical study titled "Vaccine Therapy With or Without Recombinant Interleukin-12 Followed by Daclizumab in Treating Patients With Metastatic Melanoma". This randomized phase II trial is studying how well giving vaccine therapy together with or without recombinant interleukin-12 followed by daclizumab works in treating patients with melanoma that has spread to other places in the body. Vaccines made from peptides or antigens may help the body build ...

What is the current status of trial NCT01307618?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-02. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01307618?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Recombinant Interleukin-12 (BIOLOGICAL), MART-1 Antigen (BIOLOGICAL), NA17.A2 Peptide Vaccine (BIOLOGICAL), Recombinant MAGE-3.1 Antigen (BIOLOGICAL).

Who is sponsoring clinical trial NCT01307618?

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

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

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, the data changelog, or report a data error.