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Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information


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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

1501-852A

NCT ID:

NCT00091689

Start Date:

September 2004

Completion Date:

January 2006

Related Keywords:

  • Melanoma
  • Advanced Metastatic Melanoma
  • Melanoma

Name

Location

Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756