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Use of 852A in Metastatic Cutaneous Melanoma.

Primary Purpose

Melanoma, Unresectable Metatstatic Cutaneous Melanoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
852A
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Oncology, Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Hotel Dieu, 1, Pace de l' Hôpital,
  • Hôpital Ste Marguerite,Service de Dermatologie
  • Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf
  • Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen
  • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • (DKFZ) an der Universitäts-Hautklinik Mannheim
  • Universitätsklinik und Poliklinik für Hautkrankheiten
  • Universitatsspital Zurich

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
October 24, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00189332
Brief Title
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

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Unresectable Metatstatic Cutaneous Melanoma
Keywords
Oncology, Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
852A
Primary Outcome Measure Information:
Title
assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks
Secondary Outcome Measure Information:
Title
to assess the safety of the dosage regiment over 12 weeks
Title
to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hôpital Hotel Dieu, 1, Pace de l' Hôpital,
City
Lyon
Country
France
Facility Name
Hôpital Ste Marguerite,Service de Dermatologie
City
Marseilles
Country
France
Facility Name
Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
Country
Germany
Facility Name
(DKFZ) an der Universitäts-Hautklinik Mannheim
City
Mannheim
Country
Germany
Facility Name
Universitätsklinik und Poliklinik für Hautkrankheiten
City
Würzburg
Country
Germany
Facility Name
Universitatsspital Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Use of 852A in Metastatic Cutaneous Melanoma.

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