Use of 852A in Metastatic Cutaneous Melanoma.

Melanoma Clinical Trial

Official title:

Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189332
• Other study ID #: 1527-852A
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: October 24, 2008
• Start date: February 2005
• Est. completion date: August 2006

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: SwissmedicFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Unresectable Metatstatic Cutaneous Melanoma

Intervention

Drug:
• 852A

Locations

Country	Name	City	State
France	Hôpital Hotel Dieu, 1, Pace de l' Hôpital,	Lyon
France	Hôpital Ste Marguerite,Service de Dermatologie	Marseilles
Germany	Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf	Düsseldorf
Germany	Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen	Essen
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel
Germany	(DKFZ) an der Universitäts-Hautklinik Mannheim	Mannheim
Germany	Universitätsklinik und Poliklinik für Hautkrankheiten	Würzburg
Switzerland	Universitatsspital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks
Secondary	to assess the safety of the dosage regiment over 12 weeks
Secondary	to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks