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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT00046735
Eligibility Criteria:
Inclusion Criteria:
1. Patient must understand and voluntarily sign an informed consent document.
2. Age 18 years at the time of signing Informed Consent
3. Histologically or cytologically documented solid tumors that are refractory to standard/conventional therapy or for which no standard/conventional therapy exists.
4. Patients must have at least one measurable or non-measurable lesion according to the RECIST Criteria (Appendix I).
5. Patient has an ECOG (Zubrod) performance status of ≤ 2.
6. Approximate life expectancy greater than 3 months.
7. Laboratory tests within these ranges:
* Absolute neutrophil count ≥ 1,500/μlL
* Platelet count ≥100,000/μL
* Serum creatinine ≤1.5 mg/dL
* Total bilirubin ≤1.5 mg/dL
* AST (SGOT)/ALT(SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases present
8. The following prior treatments are allowable under this protocol:
9. Radiation, if discontinued at least 4 weeks prior to treatment under this protocol Chemotherapy, if discontinued at least 4 weeks prior to treatment under this protocol, and at least 6 weeks prior to treatment under this protocol for prior nitrosurea or mitomycin-C treatment
10. Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment under this protocol
11. Other investigational drugs, if discontinued at least 4 weeks prior to treatment under this protocol
12. Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this protocol, or at least 4 weeks since major surgery
13. Patient must be able to adhere to the study visit schedule and other protocol requirements.
14. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days prior to baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
Exclusion Criteria
1. Myocardial infarction within the previous 6 months, unstable angina,symptomatic congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
2. Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event in the previous 6 months.
3. Active infection, including known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
4. CNS metastases, unless controlled by previous radiation and the patient is neurologically stable.
5. Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or limit survival to less than 3 months.
6. Pregnant or nursing females.Female patients of childbearing potential who are unwilling to use reliable contraceptive methods.
7. Any condition, including the presence of laboratory abnormalities, which in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00046735
Study Brief:
Protocol Section:
NCT00046735