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Inclusion/exclusion criteria
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible
for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
- Males or females age ≥ 18 years
- Stage
IIIb, IIIc or stage IV disease that is not surgically resectable
- Injectable disease (i.e. suitable for direct injection or through
the use of ultrasound guidance)
- At least 1 injectable cutaneous,
subcutaneous or nodal melanoma lesion >10 mm in longest diameter
or, multiple injectable melanoma lesions which in aggregate have
a longest diameter of >10 mm
- Serum
LDH levels less than 1.5 x ULN.
- ECOG Performance Status of 0 or 1.
Exclusion Criteria:
- Clinically active cerebral or any bone metastases.
Patients with up to 3 (neurological performance status of 0) cerebral
metastases may be enrolled, provided that all lesions have been adequately
treated with stereotactic radiation therapy, craniotomy, or gammaknife
therapy, with no evidence of progression, and have not required steroids,
for at least two (2) months prior to randomization.
- Greater than 3 visceral
metastases (this does not include lung metastases or nodal metastases
associated with visceral organs). For patients with <3 visceral
metastases, no lesion >3 cm, and liver lesions must meet RECIST
criteria for SD for at least 1 month prior to randomization.
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