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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00091689
First received: September 15, 2004
Last updated: October 24, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Melanoma
Drug: 852A
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Study Start Date: September 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091689

Locations
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
Pfizer
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00091689     History of Changes
Other Study ID Numbers: 1501-852A
Study First Received: September 15, 2004
Last Updated: October 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Advanced Metastatic Melanoma

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

ClinicalTrials.gov processed this record on April 17, 2014