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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00003451
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed residual, recurrent, or metastatic malignant melanoma or other advanced malignancies
* Must have failed standard curative and/or palliative therapies
* No brain or central nervous system metastases
PATIENT CHARACTERISTICS:
* Age: 13 and over
* Performance status: Karnofsky 70-100%
* Life expectancy: At least 12 weeks
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (may be posttransfusion or may receive erythropoietin)
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 2 times ULN
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 60 mL/min
* Calcium no greater than 11 mg/dL (may receive agents to decrease calcium)
* No significant cardiovascular disease
* No cardiac arrhythmia requiring drug or device intervention
* No history of significant peripheral neuropathy
* No significant central nervous system disease
* HIV negative Hepatitis B surface antigen negative
* No concurrent serious infection requiring intravenous antibiotic therapy
* No clinically significant autoimmune disease (i.e., rheumatoid arthritis)
* No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer disease
* No history of inflammatory bowel disease
* No other major illness that substantially increases the risk associated with participation in this study
* Not pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior biologic therapy
* At least 4 weeks since prior chemotherapy
* No concurrent systemic corticosteroids
* At least 2 weeks since prior local radiotherapy
* At least 2 weeks since surgery Other: At least 4 weeks since prior investigational drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00003451
Study Brief:
Protocol Section:
NCT00003451