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

Melanoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091689
• Other study ID #: 1501-852A
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2004
• Last updated: October 24, 2008
• Start date: September 2004
• Est. completion date: January 2006

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• 852A

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,