Use of 852A in Metastatic Cutaneous Melanoma.

NCT ID: NCT00189332

Last Updated: 2008-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma Unresectable Metatstatic Cutaneous Melanoma

Keywords

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Oncology Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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852A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Locations

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

Lyon, , France

Site Status

Hôpital Ste Marguerite,Service de Dermatologie

Marseille, , France

Site Status

Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf

Düsseldorf, , Germany

Site Status

Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen

Essen, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, , Germany

Site Status

(DKFZ) an der Universitäts-Hautklinik Mannheim

Mannheim, , Germany

Site Status

Universitätsklinik und Poliklinik für Hautkrankheiten

Würzburg, , Germany

Site Status

Universitatsspital Zurich

Zurich, , Switzerland

Site Status

Countries

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France Germany Switzerland

Other Identifiers

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1527-852A

Identifier Type: -

Identifier Source: org_study_id