NCT00626860

Brief Summary

This study aims to determine if the vacccine can be used safely in patients with advanced melanoma (cancer of the pigment cells) and whether the cells in this vaccine are capabale of producing immune responses against your own cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_1

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, 2000

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2008

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

February 21, 2008

Last Update Submit

January 21, 2026

Conditions

Metastatic Melanoma

Keywords

melanoma

Outcome Measures

Primary Outcomes (1)

  • To assess the toxicity, cellular and humoral immunity and tumor response in patient with melanoma receiving the DC/tumor fusion vaccine

    screening/baseline, treatment period and follow-up

Interventions

DC/tumor fusion vaccineBIOLOGICAL

SC vaccinations administered to each patient at 3-week intervals for 2-3 doses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with confirmed diagnoses of disseminated melanoma, with measurable and clearly progressive metastatic involevment
  • Patients must be at least 18 years old
  • Patients must have ECOG performance status 0-1 with greater than 9 week life expectancy
  • Those patients with the following accessible tumor will be eligible: soft tissue, bone marrow or visceral lesions; Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia; Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy may potentially be eligible; Malignant ascites or pleural effusion; Patients requiring major surgical intervention will be considered ineligible. Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study.
  • Labs: WBC \>\_ 2.0 x 10x3/uL, Bilirubin \<\_2.0 mg/dL, Creatine \<\_ 2.0mg/dL
  • Women of childbearing age must have a negative pregnancy test and adequate contraception method(s) must be documented
  • All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines

You may not qualify if:

  • Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry
  • Patients must not have received chemotherapy for three weeks prior to the first vaccination
  • Patients must be without evidence of active CNS disease
  • Patients must not have clinically significant autoimmune disease
  • Patients must be HIV negative
  • Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
  • Patients requiring corticosteroids for either melanoma related or co-morbid illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIDMC

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David Avigan, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 21, 2008

First Posted

February 29, 2008

Study Start

July 1, 2000

Primary Completion

January 1, 2002

Study Completion

September 10, 2008

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

US(1)