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NCT00089063 · ClinicalTrials.gov registry record · Phase 2

Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma

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

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT00089063: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00089063 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00089063, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make a stronger immune response.

Interventions

  • DRUG Montanide ISA 51 VG
  • BIOLOGICAL incomplete Freund's adjuvant
  • BIOLOGICAL gp100 antigen
  • BIOLOGICAL MART-1 antigen
  • BIOLOGICAL tyrosinase peptide

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2004-06
Est. Completion 2007-06
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00089063

The ClinicalTrials.gov registry entry for NCT00089063 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 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 Montanide ISA 51 VG is the first listed.

NCT00089063 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00089063 about?

NCT00089063 is a clinical study titled "Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma". This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an im...

What is the current status of trial NCT00089063?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2004-06. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00089063?

The interventions under investigation include: Montanide ISA 51 VG (DRUG), incomplete Freund's adjuvant (BIOLOGICAL), gp100 antigen (BIOLOGICAL), MART-1 antigen (BIOLOGICAL), tyrosinase peptide (BIOLOGICAL).

Who is sponsoring clinical trial NCT00089063?

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.