Safety and Efficacy of an Immune Response Modifier to Treat Inoperable Advanced Melanoma Skin Lesions
NCT00091689
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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
- 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.
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Descriptive Information | |||
---|---|---|---|
Brief Title ICMJE | Safety and Efficacy of an Immune Response Modifier to Treat Inoperable Advanced Melanoma Skin Lesions | ||
Official Title ICMJE | Not Provided | ||
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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
Condition ICMJE | Melanoma | ||
Intervention ICMJE | Drug: 852A | ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date ICMJE | January 2006 | ||
Actual Primary Completion Date | January 2006 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
Sex/Gender ICMJE |
| ||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00091689 | ||
Other Study ID Numbers ICMJE | 1501-852A | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||
Study Sponsor ICMJE | Pfizer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Pfizer | ||
Verification Date | October 2008 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |