Treatment Use Study for Advanced 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: NCT00584493
Recruitment Status : No longer available
First Posted : January 2, 2008
Last Update Posted : December 14, 2009
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Brief Summary:
The purpose of this study is to provide access to CP-675,206 for patients with advanced unresectable melanoma and who have the potential to gain benefit from this treatment and who are not eligible for participation in other CP-675,206 studies.

Condition or disease Intervention/treatment
Advanced Unresectable Melanoma Drug: CP-675,206

Detailed Description:
This is an expanded access trial that canceled prior to enrolling patients.

Study Type : Expanded Access
Official Title: Treatment Use Study of CP-675,206 for Advanced Melanoma
Study Start Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Intervention Details:
    Drug: CP-675,206

    This is a single arm study. Patients will receive intravenous administration of CP-675,206 at a dose of 15 mg/kg on Day 1 of every 90-day cycle for up to 4 cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 (± 4 day) period. Patients who discontinue treatment after 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 2 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma

    Survival in this study will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Advanced melanoma with life expectancy of at least 6 months.
  • Melanoma must be considered unresectable.
  • Patients with stable, treated brain mets must be stable clinically and radiographically and off steroids for at least one month.

Exclusion Criteria:

  • Patients must not be eligible for participation in any ongoing CP-675,206 clinical studies currently open for enrollment.
  • History of chronic inflammatory or autoimmune disease.
  • History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, active colitis, history of diverticulitis.

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): NCT00584493

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00584493     History of Changes
Other Study ID Numbers: A3671028
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: December 14, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs