Treatment Use Study for Advanced Melanoma.

NCT00584493 | Unknown

• 1 other identifier: A3671028
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Unresectable Melanoma

Interventions

CP-675,206 DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

tremelimumab

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: May 1, 2008
• Last Updated: December 14, 2009

Record last verified: 2009-12