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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091689
Recruitment Status : Completed
First Posted : September 17, 2004
Last Update Posted : October 27, 2008
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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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: 852A Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00091689

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00091689     History of Changes
Other Study ID Numbers: 1501-852A
First Posted: September 17, 2004    Key Record Dates
Last Update Posted: October 27, 2008
Last Verified: October 2008

Keywords provided by Pfizer:
Advanced Metastatic Melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas