Status:
COMPLETED
Use of 852A in Metastatic Cutaneous Melanoma.
Lead Sponsor:
Pfizer
Conditions:
Melanoma
Unresectable Metatstatic Cutaneous Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00189332
Start Date
February 1 2005
End Date
August 1 2006
Last Update
October 27 2008
Active Locations (8)
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1
Hôpital Hotel Dieu, 1, Pace de l' Hôpital,
Lyon, France
2
Hôpital Ste Marguerite,Service de Dermatologie
Marseille, France
3
Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf
Düsseldorf, Germany
4
Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen
Essen, Germany