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Use of 852A in Metastatic Cutaneous Melanoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189332
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : October 27, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Melanoma Unresectable Metatstatic Cutaneous Melanoma Drug: 852A Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : February 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

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

Secondary Outcome Measures :
  1. to assess the safety of the dosage regiment over 12 weeks
  2. to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189332

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Hôpital Hotel Dieu, 1, Pace de l' Hôpital,
Lyon, France
Hôpital Ste Marguerite,Service de Dermatologie
Marseilles, France
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
Universitatsspital Zurich
Zurich, Switzerland
Sponsors and Collaborators
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00189332    
Other Study ID Numbers: 1527-852A
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: October 27, 2008
Last Verified: October 2008
Keywords provided by Pfizer:
Additional relevant MeSH terms:
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Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases