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Use of 852A in Metastatic Cutaneous Melanoma.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00189332
First received: September 13, 2005
Last updated: October 24, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Melanoma
Unresectable Metatstatic Cutaneous Melanoma
 Drug: 852A
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 28
Study Start Date: February 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189332

Locations
France
Hôpital Hotel Dieu, 1, Pace de l' Hôpital,
Lyon, France
Hôpital Ste Marguerite,Service de Dermatologie
Marseilles, France
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, Germany
Switzerland
Universitatsspital Zurich
Zurich, Switzerland
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00189332     History of Changes
Other Study ID Numbers: 1527-852A
Study First Received: September 13, 2005
Last Updated: October 24, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Pfizer:
Oncology
Melanoma

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013