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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT00004250
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven primary or recurrent, regional melanoma or soft tissue sarcoma that is not amenable to surgical resection
* Majority (greater than 95%) of disease must be distal to the apex of the femoral triangle in the lower limb and the deltoid insertion in the upper limb
* Bidimensionally measurable disease in the extremity
* Patients with disease beyond the limb are eligible if their extremity disease requires palliative treatment in the judgment of their physician
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Karnofsky 70-100%
Life expectancy:
* At least 6 months
Hematopoietic:
* WBC at least 3,000/mm\^3
Hepatic:
* Not specified
Renal:
* Creatinine less than 2.0 mg/dL
Cardiovascular:
* Must have palpable femoral/axillary, dorsalis pedis/popliteal, or radial pulses in the extremity to be treated
* No signs or symptoms of vascular insufficiency (no history of claudication or other ischemic peripheral vascular disease)
Other:
* Not pregnant or nursing
* Negative pregnancy test
* No other concurrent serious illness
* No severe diabetes
* No prior extremity complications due to diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 4 weeks since prior antitumor therapy and recovered
* At least 2 weeks since prior antibiotics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004250
Study Brief:
Protocol Section:
NCT00004250