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

NCT00091689 | Completed Phase 1

• 1 other identifier: 1501-852A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Melanoma

Keywords

Advanced Metastatic Melanoma

Interventions

852A DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2004
• First Posted: September 17, 2004
• Study Start: September 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: October 27, 2008

Record last verified: 2008-10

Locations

US (2)