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Clinical Trials/NCT00091689
NCT00091689CompletedPhase 1

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

Pfizer2 sites in 1 countryStarted: September 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Pfizer
Locations
2
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Investigators

Sponsor
Pfizer
Sponsor Class
Industry

Study Sites (2)

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