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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT00085059
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma
* Metastatic disease
* Brain metastases, skin metastases, or soft tissue metastases of the head and neck or the extremities
* Accessible lesion(s) for boron neutron capture therapy (BNCT)
* No clear progression of disease at other sites than the ones intended for treatment with surgery and/or BNCT
* Measurable disease by MRI within the past 4 weeks
* Lesion(s) ≥ 10 mm in diameter
* Indication for palliative radiotherapy that is intended to be delivered as BNCT
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
Hepatic
* Bilirubin ≤ 2.5 times upper limit of normal (ULN)\*
* Transaminases ≤ 2.5 times ULN\*
* Alkaline phosphatase ≤ 2.5 times ULN\* NOTE: \*Unless due to reversible reaction to antiseizure medication
Renal
* Creatinine ≤ 2.5 times ULN
* Blood urea nitrogen ≤ 2.5 times ULN
Cardiovascular
* No congestive heart failure
* No newly diagnosed or unstable angina pectoris
* No uncontrolled arrhythmias
* No uncontrolled conduction defects
* No recent coronary artery disease
* No other severe heart disease
Pulmonary
* No severe pulmonary disease, including severe obstructive or restrictive lung disease
Other
* No history of phenylketonuria
* No severe gastrointestinal disease
* No active peptic ulcer disease
* No uncontrolled endocrine disease
* No pre-existing serious mental or organic brain disease (e.g., epilepsy)
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* Able to travel to the Netherlands via public transportation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunologic or biologic therapy
* No concurrent colony-stimulating factors (e.g., epoetin alfa or filgrastim \[G-CSF\])
Chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy
Radiotherapy
* No prior radiotherapy to site(s) proposed for study treatment
* No other concurrent radiotherapy
Surgery
* See Disease Characteristics
Other
* Recovered from all prior anti-tumor therapy (excluding alopecia and sensitive peripheral neuropathy ≤ grade 2)
* No other concurrent anticancer therapy
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00085059
Study Brief:
Protocol Section:
NCT00085059