Safety and Efficacy of an Immune Response Modifier to Treat Inoperable Advanced Melanoma Skin Lesions

Phase 1

Completed

• Conditions: Melanoma

• Registration Number: NCT00091689
• Lead Sponsor: Pfizer

Brief Summary

Study 1501-852A is a Phase 1 Study with the objective of determining safety and the highest tolerated dose of an immune response modifier cream directly applied to advanced, inoperable, melanoma skin lesions. The study will also measure blood levels of the drug and examine the potential anti-tumor activity of the cream.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2004-09-15
• Study First Submitted QC: 2004-09-16
• Study First Posted: 2004-09-17
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-24
• Last Update Posted: 2008-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Have melanoma cutaneous metastasis or lentigo maligna melanoma unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Have a life expectancy of 4 months
• Have normal organ and bone marrow function

Exclusion Criteria

• Need for non-steroidal anti-inflammatory drugs (NSAIDs) during the study
• Have a body mass index (BMI)> 30 kg/m2
• Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months
• Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements
• Have a history of disease requiring ongoing steroid treatment
• Have a history of seizure disorder (other than febrile seizures in childhood)
• Have a history of clinically significant coagulation or bleeding disorders or abnormalities
• Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (2)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Oklahoma Medical Research Foundation; 🇺🇸 Oklahoma City, Oklahoma, United States