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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT00048334
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Patients must have histologic or cytologic confirmation of cancer (excluding acute leukemia) for which there is no known standard therapy capable of extending life expectancy.
2. Patients must:
* Be age greater than or equal to 18 years.
* Have evaluable disease.
* Have a performance status of ECOG 0-2.
* Have no serious or intercurrent illness that can not be medically controlled and have a have a life expectancy of greater than 12 weeks.
* Give written informed consent.
* Be willing to return to National Cancer Institute for follow-up.
* Female patients of childbearing potential must have a negative pregnancy test within 1 week and must use effective contraception (hormonal or barrier methods) while being treated on protocol.
3\. Laboratory values:
* Within 7 days prior to registration: absolute neutrophil count greater than or equal to 1000/microL, platelets greater than or equal to l00,000/microL, bilirubin (total and direct) less than or equal to 1.5x upper limit of normal, and AST less than or equal to 3x upper limit of normal, creatinine less than or equal to1.5x upper limit of normal, or documented creatinine clearance of greater than or equal to 60mL/min.
* Within 4 weeks of registration: ejection fraction of greater than 50% by echocardiogram or cardiac MRI, or 45% by MUGA scan.
4\. Criteria for cohort of patients with RAI refractory non-medullary thyroid cancer to be enrolled after the MTD has been defined:
* Non-medullary thyroid carcinoma.
* progressive disease following total or near-total thyroidectomy and RAI therapy.
* Documented evidence of no, or minimally ( faint ), RAI uptake on RAI whole body scan.
* no RAI therapy within 3 months prior to study entry.
* no history of administration of IV iodinated contrast or other large iodine loads (i.e. CT, amiodarone, SSKI) during the previous 3 months.
* 24 hr urinary iodine values less than or equal to150 microg/day.
EXCLUSION CRITERIA
1. Patients with unconfirmed diagnosis will be excluded.
2. Prior or concurrent malignancies that have not been curatively treated.
3. Current or previous CNS metastasis.
4. Chemotherapy within 4 weeks, 6 weeks for nitrosoureas or mitomycin C, and 8 weeks for UCN-01.
5. HIV seropositivity.
6. Pregnant or breast-feeding patients.
7. Uncontrolled infection.
8. Patients with the following cardiac risk factors will be excluded from the study:
* Patients with known cardiac abnormalities such as: Congenital long QT syndrome and -QTc interval greater than 480 milliseconds
* Patients who have had a myocardial infarction within 12 months of study entry.
* Patients who have active coronary artery disease, e.g. angina as defined by Canadian Class II-IV
* Patients with an ECG recorded at screening showing evidence of cardiac ischemia (ST depression of greater than or equal to 2 mm).
* Any patient in whom coronary artery disease is suspected should be referred for a cardiology consultation and if active myocardial ischemia is demonstrated, the patient should be excluded. If a noninvasive imaging study is equivocal, it may be necessary to proceed to coronary angiography.
* Patients with congestive heart failure that meets NYHA Class II to IV definitions and/or ejection fraction less than 45% by MUGA scan or less than 50% by echocardiogram and/or MRI.
* Patients with a history of sustained VT, VF, Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD). Patients with a history of arrhythmia should have Holter monitoring and evaluation by cardiology.
* Patients with dilated, hypertrophic, or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above). Patients with left ventricular hypertrophy should be discussed with the Principal Investigator or Study Chairman.
* Patients with uncontrolled hypertension, i.e. SBP greater than or equal to 160 mm Hg or DBP greater than or equal to 95 mm Hg.
* Patients with cardiac arrhythmia requiring anti-arrhythmic medication other than beta blocker or calcium channel blocker. Patients in whom digitalis cannot be discontinued are excluded from study.
* Patients with Mobitz II second degree heart block who do not have a pacemaker. Patients with first degree or Mobitz I second degree heart block, bradyarrhythmias or sick sinus syndrome require Holter monitoring and evaluation by cardiology.
* Patients with other cardiac disease may be excluded at the discretion of the PI following consultation with cardiology.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00048334
Study Brief:
Protocol Section:
NCT00048334