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

NCT00005617 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-08-03

No results posted yet for this study

Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV, or relapsed malignant melanoma.

Conditions

Interventions

BIOLOGICAL

dendritic cell-MART-1 peptide vaccine

Number DC: dependent on the group route of immunization: dependent on the group subjects will receive 3 biweekly vaccinations. In case of grade III-IV toxicity in 1/3 subjects at any dose group or route, up to 6 subjects will be included in that group.

PROCEDURE

leukapheresis

Patients require a single leukapheresis to obtain 2x10\^9 PBL, which are cryopreserved in RPMI 1640, 20% autologous serum, 10% DMSO. Aliquots are thawed at days -7, 7 and 21 for the first, second, and third immunizations respectively. Blood is drawn at the time of leukapheresis and on the day of the first vaccination for autologous serum, which is sufficient for the cell cultures of all patient groups.

Sponsors & Collaborators

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • John A Glaspy, MD · Jonsson Comprehensive Cancer Center

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-07-31
Primary Completion
2002-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00005617 on ClinicalTrials.gov