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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT00625456
Eligibility Criteria:
Inclusion Criteria:
* Histologically-confirmed, advanced/metastatic solid tumor refractory to standard therapy or the patient has refused or does not tolerate the standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck
* At least one measurable tumor mass by CT/MRI (i.e. lesion that can accurately be measured in at least one dimension with longest diameter \> 1 cm)
* At least one tumor mass amenable to biopsy and/or FNA
* Expected survival for approximately 16 weeks or longer
* Karnofsky Performance Score (KPS) ≥ 70
* Age ≥18 years
* WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3
* ANC ≥ 1,500 cells/mm3
* Hemoglobin ≥ 10 g/dL
* Platelet count ≥ 100,000 plts/mm3
* Total bilirubin ≤ 1.5 x ULN
* AST, ALT ≤ 2.5 x ULN
* Serum chemistries within normal limits (WNL) or Grade 1 - If patients are diabetic or have a screening random glucose \> 160 mg/dL, a fasting glucose must be done and patients must be WNL or Grade 1 in order to be eligible for the study.
* Acceptable coagulation status: INR ≤ (ULN + 10%)
* CD4 count ≥ 500/mm3
Exclusion Criteria:
* Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
* Known myeloproliferative disorders requiring systemic therapy
* History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring systemic therapy
* Tumor(s) invading a major vascular structure (e.g. carotid artery)
* Tumor(s) in location that would potentially result in significant clinical adverse effects if post-treatment tumor swelling were to occur (e.g. tumors impinging on the upper airway or affecting biliary tract drainage, etc.)
* Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
* Severe or unstable cardiac disease
* Current, known CNS malignancy (history of completely resected or irradiated brain metastases allowed)
* Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas)
* Use of anti-viral, anti-platelet, or anti-coagulation medication \[Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.\]
* Pulse oximetry O2 saturation \<90% at rest
* Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
Household contact exclusions:
* Women who are pregnant or nursing an infant
* Children \< 5 years old
* History of exfoliative skin condition (e.g. eczema) that at some stage has required systemic therapy
* Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00625456
Study Brief:
Protocol Section:
NCT00625456