Clinical trial NCT00189332: Use of 852A in Metastatic Cutaneous Melanoma.
Official title: Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Unresectable Metatstatic Cutaneous Melanoma
Keywords: Oncology
Melanoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks
Secondary outcomes:
measure: to assess the safety of the dosage regiment over 12 weeks
measure: to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Hotel Dieu, 1, Pace de l' Hôpital,
city: Marseilles
country: France
facility: Hôpital Ste Marguerite,Service de Dermatologie
city: Düsseldorf
country: Germany
facility: Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf
city: Essen
country: Germany
facility: Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Mannheim
country: Germany
facility: (DKFZ) an der Universitäts-Hautklinik Mannheim
city: Würzburg
country: Germany
facility: Universitätsklinik und Poliklinik für Hautkrankheiten
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
Study officials:
References: