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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Melanoma

Treatments

Drug: 852A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00091689

1501-852A

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.