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Completed

NCT Number: NCT00189332

Use of 852A in Metastatic Cutaneous Melanoma.

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Unresectable Metatstatic Cutaneous Melanoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Hotel Dieu, 1, Pace de l' Hôpital,, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

852A

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Oct 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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