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NCT00079144 · ClinicalTrials.gov registry record · Phase 2

Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion, Peptide Vaccine Plus Montanide ISA-51, and Interleukin-2 in Treating Patients With Metastatic Melanoma

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

Completed
Registry status
Phase 2
Development phase
2
Study locations

NCT00079144 is a Phase 2 study of Melanoma (Skin) that has completed, run by National Cancer Institute (NCI). The trial reports 2 study locations across 1 state.

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The verdict

NCT00079144, a Phase 2 study of Melanoma (Skin), has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
2
Study locations

Study Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Treating a person's lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed by chemotherapy. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells. PURPOSE: This phase II trial is studying how well lymphocyte-depleting nonmyeloablative (not damaging to bone marrow) chemotherapy followed by autologous lymphocyte infusion, peptide vaccine plus Montanide ISA-51, and interleukin-2 works in treating patients with metastatic melanoma.

Conditions Studied

Interventions

  • BIOLOGICAL therapeutic autologous lymphocytes
  • BIOLOGICAL aldesleukin
  • BIOLOGICAL filgrastim
  • BIOLOGICAL NY-ESO-1 peptide vaccine
  • BIOLOGICAL incomplete Freund's adjuvant

Study Locations (2)

Maryland

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support - Bethesda
  • NCI - Center for Cancer Research - Bethesda

Trial Details

FieldValue
Start Date 2004-01
Est. Completion 2005-08
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00079144

The ClinicalTrials.gov registry entry for NCT00079144 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Cancer Institute (NCI), which has 3,257 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 therapeutic autologous lymphocytes is the first listed.

NCT00079144 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00079144 about?

NCT00079144 is a clinical study titled "Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion, Peptide Vaccine Plus Montanide ISA-51, and Interleukin-2 in Treating Patients With Metastatic Melanoma". RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Treating a person's lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed by chemotherapy. Vaccines ma...

What is the current status of trial NCT00079144?

This trial is currently completed. It is a Phase 2 study. The study started on 2004-01. Estimated completion is 2005-08.

What conditions does trial NCT00079144 study?

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

What interventions are being tested in trial NCT00079144?

The interventions under investigation include: therapeutic autologous lymphocytes (BIOLOGICAL), aldesleukin (BIOLOGICAL), filgrastim (BIOLOGICAL), NY-ESO-1 peptide vaccine (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL).

Who is sponsoring clinical trial NCT00079144?

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

Where is trial NCT00079144 being conducted?

This trial has 2 study locations 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.