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:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT00311558
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignancy, including, but not limited to, any of the following:
* Renal cell carcinoma
* Melanoma
* Kaposi's sarcoma
* Breast, prostate, colorectal, or lung adenocarcinoma
* Bone and soft tissue sarcomas
* Lymphoma
* Myeloma
* Tumors of neuroendocrine and endothelial cell origin
* Stage IV disease
* Refractory disease, resistant to established treatments, or no effective treatment available
* Measurable or evaluable disease
* CNS metastases allowed if no prior definitive therapy within the past 3 months and no glucocorticoids required
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Granulocyte count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Creatinine \< 1.0 times upper limit of normal (ULN)
* Creatinine clearance ≥ 60 mL/min
* Bilirubin \< 1.5 times ULN
* AST/ALT \< 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No history of any of the following:
* Atrial fibrillation, atrial flutter, or other serious arrhythmia (excluding asymptomatic atrial and ventricular premature complexes)
* Congestive heart failure currently requiring treatment
* Angina pectoris
* Other severe cardiovascular disease (i.e., New York Heart Association class III or IV heart disease)
* No baseline ECG abnormalities suggestive of cardiac conduction delay, i.e., 1° or greater atrio-ventricular block and/or complete or incomplete (QRS \> 120 ms) bundle branch block, or repolarization abnormalities (i.e., QTc ≥ 0.48 sec)
* No systemic infections requiring antibiotics within the past 14 days
* No known hepatitis B surface antigen positivity
* Psychologically prepared to participate in study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior interferon (IFN) therapy and/or ≤ 400 million units of IFN
* At least 3 weeks since prior major surgery
* At least 3 weeks since prior radiation therapy or chemotherapy
* No prior solid organ allografts or allogeneic bone marrow transplantation
* No concurrent daily glucocorticoids except for physiological replacement
* No other concurrent medications known to prolong QT interval
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00311558
Study Brief:
Protocol Section:
NCT00311558