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:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00019734
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic melanoma that has failed standard treatment
* No ocular or mucosal melanoma as primary site
* Measurable disease
* No existing brain metastases
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0 or 1
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC at least 3,000/mm3
* Platelet count at least 90,000/mm3
* No coagulation disorder
Hepatic:
* Bilirubin no greater than 1.6 mg/dL
* AST/ALT less than 3 times normal
* Hepatitis B surface antigen negative
Renal:
* Creatinine no greater than 1.6 mg/dL
Cardiovascular:
* No major cardiovascular illness
Pulmonary:
* No major respiratory illness
Immunologic:
* HIV negative
* No autoimmune disease
* No primary or secondary immunodeficiency
* No allergy to eggs
* No history of allergy or untoward reaction to prior smallpox vaccination
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be able to avoid close contact with children under 5 years, pregnant women, people with active or a past history of eczema or other eczematoid skin disorders, and immunosuppressed people for at least 2 weeks after each vaccinia virus vaccination
* No active systemic infections
* No active atopic dermatitis or active or past history of eczema
* No concurrent active extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin conditions or open wounds
* Surgical scars must be healed
* Healed surgical stomas (e.g., colostomy) allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior recombinant vaccinia or fowlpox vaccines for melanoma
* At least 3 weeks since prior systemic biologic therapy for melanoma
Chemotherapy:
* At least 3 weeks since prior systemic chemotherapy for melanoma
Endocrine therapy:
* At least 3 weeks since prior systemic endocrine therapy for melanoma
* No concurrent steroid therapy
Radiotherapy:
* At least 3 weeks since prior systemic radiotherapy for melanoma
Surgery:
* Prior surgery allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00019734
Study Brief:
Protocol Section:
NCT00019734