Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00022568
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma
* Lesion(s) must be accessible to percutaneous injection
* Measurable lesion(s)
* At least 1.0 cm
* Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed
* At least 6 weeks since prior definitive therapy (surgery or radiotherapy)
* No untreated or edematous metastatic brain lesions or leptomeningeal disease
* No ascites or pleural effusions
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-1
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC at least 3,000/mm3
* Platelet count at least 100,000/mm3
* Absolute granulocyte count at least 3,000/mm3
* Hemoglobin at least 10 g/dL
Hepatic:
* Direct bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN
* No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications)
* No hepatic insufficiency
* No alcoholic cirrhosis
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 60 mL/min
* No renal insufficiency
Cardiovascular:
* No congestive heart failure
* No serious cardiac arrhythmias
* No evidence of recent prior myocardial infarction on EKG
* No clinical coronary artery disease
Pulmonary:
* No chronic obstructive pulmonary disease
Immunologic:
* No prior eczema
* HIV negative
* No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds)
* No clinical or laboratory evidence of an underlying immunosuppressive disorder
* No active or chronic infections
* No significant allergy or hypersensitivity to eggs
Other:
* No active seizure disorders
* No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free
* No evidence of bone marrow toxicity
* No other concurrent medical illness that would preclude study
* No other contraindications to vaccinia virus administration
* No encephalitis
* Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior vaccinia immunization required (e.g., smallpox vaccination)
* More than 8 weeks since prior immunotherapy and recovered
* No prior therapy with live vaccinia virus vector
Chemotherapy:
* More than 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
* At least 4 weeks since prior systemic corticosteroids
* No concurrent systemic corticosteroids
* No concurrent steroids
Radiotherapy:
* See Disease Characteristics
* More than 2 weeks since prior radiotherapy and recovered
Surgery:
* See Disease Characteristics
* More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered
Other:
* No concurrent immunosuppressive drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00022568
Study Brief:
Protocol Section:
NCT00022568