Use of 852A in Metastatic Cutaneous Melanoma.
Phase 2
Completed
- Conditions
- MelanomaUnresectable Metatstatic Cutaneous Melanoma
- Registration Number
- NCT00189332
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (8)
Hôpital Ste Marguerite,Service de Dermatologie
🇫🇷Marseilles, France
Universitätsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
(DKFZ) an der Universitäts-Hautklinik Mannheim
🇩🇪Mannheim, Germany
Universitätsklinik und Poliklinik für Hautkrankheiten
🇩🇪Würzburg, Germany
Hôpital Hotel Dieu, 1, Pace de l' Hôpital,
🇫🇷Lyon, France
Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen
🇩🇪Essen, Germany
Universitatsspital Zurich
🇨🇭Zurich, Switzerland
Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf
🇩🇪Düsseldorf, Germany