MedTrace Logo

Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma

NCT00039325 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-08-03

No results posted yet for this study

Summary

RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage IV or recurrent malignant melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

dendritic cell-MART-1 peptide vaccine

Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^6 (for arm A) or 10\^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • James S. Economou, MD · Jonsson Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2005-09-30
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00039325 on ClinicalTrials.gov