NCT00125749

Brief Summary

The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with Stage IV melanoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

1.9 years

First QC Date

August 1, 2005

Last Update Submit

June 9, 2017

Conditions

MelanomaNeoplasm Metastasis

Keywords

DendriticVaccineMelanomaStage IV metastatic melanoma

Outcome Measures

Primary Outcomes (3)

  • Safety and tolerability of the novel DC vaccination product in human subjects

    3 years

  • Feasibility of a novel approach to DC manufacture

    3 years

  • Objective clinical responses

    3 years

Secondary Outcomes (1)

  • Immunogenicity of frozen DC vaccinations

    3 years

Interventions

Dendritic cell vaccinationBIOLOGICAL

Autologous Dendritic Cells Derived from PBMC, Cultured with Cytokines, Pulsed Ex Vivo with Irradiated Allogeneic (Colo 829) Melanoma Cells

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage M1a, M1b, M1c biopsy proven metastatic melanoma
  • Failure of at least one prior chemotherapy regimen of DTIC and/or temozolomide with/without interleukin-2 (IL-2).
  • Karnofsky performance status greater than/equal to 80%.
  • Measurable metastatic lesions by physical exam or scans.
  • Acceptable CBC and blood chemistry results
  • Adequate renal function.
  • Written informed consent.

You may not qualify if:

  • Patients who have received more than 8 cycles of chemotherapy for metastatic melanoma.
  • Patients who have received chemotherapy less than 4 weeks before beginning the trial.
  • Patients who have received interferon (IFN) alpha-2b or granulocyte-monocyte colony-stimulating factor (GM-CSF) less than 4 weeks before beginning the trial.
  • Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial.
  • Patients with a history of central nervous system (CNS) metastatic melanoma.
  • More than 5 hepatic lesions or any hepatic lesion larger than 5 cm.
  • Baseline serum LDH greater than 4 times the upper limit of normal.
  • Patients who are HIV positive.
  • Patients who are pregnant.
  • Patients who have received corticosteroids or other agents less than 4 weeks before beginning the trial.
  • Patients with asthma, angina pectoris or congestive heart failure.
  • Patients with autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
  • Patients with active infections including viral hepatitis.
  • Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mary Crowley Medical Research Center: Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Links

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Karolina Palucka, MD, PhD

    Baylor Institute for Immunology Research: Baylor University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2005

First Posted

August 2, 2005

Study Start

July 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations

US(1)