Use of 852A in Metastatic Cutaneous Melanoma.

Pfizer28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma Unresectable Metatstatic Cutaneous Melanoma

Interventions

852ADRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Lyon, France

Hôpital Ste Marguerite,Service de Dermatologie

Marseille, France

Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf

Düsseldorf, Germany

Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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