NCT00204594

Brief Summary

Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration 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

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

January 15, 2013

Conditions

Malignant Melanoma

Keywords

mRNAvaccinationmelanoma

Outcome Measures

Primary Outcomes (2)

  • toxicity

  • clinical response

Study Arms (1)

Antibody

EXPERIMENTAL
Drug: rM28Drug: autologous PBMCs

Interventions

rM28DRUG
Antibody
autologous PBMCsDRUG
Antibody

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • malignant melanoma stage III/IV
  • injectable soft tissue metastasis
  • informed consent given
  • Karnofsky \>= 70%

You may not qualify if:

  • additional chemotherapeutical treatment
  • systemic glucocorticoids
  • brain metestasis
  • other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tuebingen, Department of dermatology

Tübingen, 72076, Germany

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

  • Garbe Claus, Prof. Dr.

    Department of dermatology, university of tuebingen

    PRINCIPAL INVESTIGATOR

  • Gundram Jung, Prof. Dr.

    University of Tuebingen, Dept. of Immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

DE(1)