NCT00189332

Brief Summary

Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_2

Geographic Reach
3 countries

8 active sites

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

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

October 27, 2008

Status Verified

October 1, 2008

Enrollment Period

1.5 years

First QC Date

September 13, 2005

Last Update Submit

October 24, 2008

Conditions

MelanomaUnresectable Metatstatic Cutaneous Melanoma

Keywords

OncologyMelanoma

Outcome Measures

Primary Outcomes (1)

  • assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks

Secondary Outcomes (2)

  • to assess the safety of the dosage regiment over 12 weeks

  • to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks

Interventions

852ADRUG

Eligibility Criteria

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

You may qualify if:

  • Advanced melanoma not responding to 1st line chemotherapy
  • Histological evidence of melanoma
  • Measurable disease according to RECIST criteria
  • ECOG performance status less than or equal to 2
  • Life expectancy 6 months or more
  • Normal organ and bone marrow function as defined by hematological and serum chemistry limits
  • Adequate contraception for females of childbearing potential

You may not qualify if:

  • Stage IV disease which has previously progressed during interferon treatment.
  • Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes
  • History of uncontrolled seizure disorders
  • Uncontrolled coagulation disorders.
  • History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months
  • History of uncontrolled intercurrent or chronic illness
  • Concurrent malignancies.
  • Brain metastases.
  • HIV positive.
  • Prolonged QTc interval
  • Uncontrolled intercurrent or chronic illnesses.
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hôpital Hotel Dieu, 1, Pace de l' Hôpital,

Lyon, France

Location

Hôpital Ste Marguerite,Service de Dermatologie

Marseille, France

Location

Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf

Düsseldorf, Germany

Location

Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen

Essen, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

(DKFZ) an der Universitäts-Hautklinik Mannheim

Mannheim, Germany

Location

Universitätsklinik und Poliklinik für Hautkrankheiten

Würzburg, Germany

Location

Universitatsspital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

MelanomaNeoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

February 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

October 27, 2008

Record last verified: 2008-10

Locations

FR(2)DE(5)CH(1)