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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT00054535
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of metastatic melanoma
* Measurable disease
* Disease progression while receiving prior standard treatment
* No ocular or mucosal primary site
* No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age
* 16 and over
Performance status
* ECOG 0-1
Life expectancy
* More than 3 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Platelet count at least 90,000/mm\^3
* No coagulation disorders
Hepatic
* Bilirubin no greater than 1.6 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome)
* AST/ALT less than 3 times normal
* Hepatitis B surface antigen negative
* Hepatitis C antibody 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 active systemic infections
* No primary or secondary immunodeficiency (e.g., hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome or acquired immunodeficiencies after bone marrow transplantation)
* No allergy to eggs
* No prior allergy or untoward reaction to smallpox vaccination (if previously vaccinated)
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No close contact with the following individuals for 2 weeks after vaccinia vaccination:
* Children under 5 years of age
* Pregnant women
* Individuals with prior or active eczema or other eczematoid skin disorders
* Individuals with other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
* Immunosuppressed individuals
* No active atopic dermatitis
* No prior or active eczema
* No active cases of the following conditions:
* Extensive psoriasis
* Severe acneiform rash
* Impetigo
* Varicella zoster
* Burns
* Traumatic or pruritic skin conditions
* Open wounds
* No unhealed surgical scars
* Healed surgical stomas (e.g., colostomy) allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior recombinant vaccinia or fowlpox vaccines for melanoma
* No prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma
* Prior individual tyrosinase peptides are allowed
* No prior high-dose interleukin-2
Chemotherapy
* Not specified
Endocrine therapy
* No concurrent oral, IV, topical, or inhaled steroids
Radiotherapy
* Not specified
Surgery
* Recovered from prior surgery
Other
* Recovered from prior therapy for melanoma
* More than 3 weeks since prior systemic therapy for melanoma
* No other concurrent systemic therapy for melanoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00054535
Study Brief:
Protocol Section:
NCT00054535