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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-01-31

Brief Summary

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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

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Conditions

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Melanoma

Keywords

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Advanced Metastatic Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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852A

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pfizer, Inc.

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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1501-852A

Identifier Type: -

Identifier Source: org_study_id