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NCT00118274 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma

A Phase 1 study of Melanoma (Skin), sponsored by Craig L Slingluff, Jr.

Completed
Registry status
Phase 1
Development phase
170
Enrollment target
3
Study locations

NCT00118274 is a Phase 1 study of Melanoma (Skin) that has completed, run by Craig L Slingluff, Jr. The registered enrollment target is 170 participants, above the 131-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (30% higher). The trial reports 3 study locations across 3 states.

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The verdict

NCT00118274, a Phase 1 study of Melanoma (Skin), has completed, sponsored by Craig L Slingluff, Jr.

COMPLETED
Registry status
Phase 1
Development phase
170 participants
Enrollment target
3
Study locations

Study Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma. PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Conditions Studied

Interventions

  • DRUG cyclophosphamide
  • BIOLOGICAL incomplete Freund's adjuvant
  • BIOLOGICAL melanoma helper peptide vaccine
  • BIOLOGICAL multi-epitope melanoma peptide vaccine
  • BIOLOGICAL tetanus toxoid helper peptide

Study Locations (3)

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia - Philadelphia

Texas

  • M. D. Anderson Cancer Center at University of Texas - Houston

Virginia

  • University of Virginia Cancer Center - Charlottesville

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2005-03
Est. Completion 2010-02
Phase Phase 1

Sponsor

Craig L Slingluff, Jr

23 total trials

What the Registry Record Tells You About NCT00118274

The ClinicalTrials.gov registry entry for NCT00118274 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 131-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (30% higher). The listed sponsor is Craig L Slingluff, Jr, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00118274 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Pennsylvania, Texas, Virginia.

Frequently Asked Questions

What is clinical trial NCT00118274 about?

NCT00118274 is a clinical study titled "Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma". RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophospha...

What is the current status of trial NCT00118274?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2005-03. Estimated completion is 2010-02.

What conditions does trial NCT00118274 study?

This clinical trial studies the following conditions: Melanoma (Skin).

What interventions are being tested in trial NCT00118274?

The interventions under investigation include: cyclophosphamide (DRUG), incomplete Freund's adjuvant (BIOLOGICAL), melanoma helper peptide vaccine (BIOLOGICAL), multi-epitope melanoma peptide vaccine (BIOLOGICAL), tetanus toxoid helper peptide (BIOLOGICAL).

Who is sponsoring clinical trial NCT00118274?

This trial is sponsored by Craig L Slingluff, Jr, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00118274 being conducted?

This trial has 3 study locations across Pennsylvania, Texas, Virginia. 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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