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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00103220
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed solid tumor
* Advanced disease, defined as metastatic or unresectable disease
* Measurable indicator lesions
* Standard curative or palliative measures do not exist or are no longer effective
* Previously treated CNS metastases allowed provided patient has completed local therapy AND corticosteroids have been discontinued for at least 4 weeks
* No known leptomeningeal metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 3 months
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.0 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine \< 1.4 mg/dL
* No congestive heart failure
* No recent myocardial infarction
* No unstable angina
* No uncontrolled hypertension
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
* No other significant medical history, unstable medical condition, or unstable systemic disease that would preclude study participation
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and 8 weeks for UCN-01)
* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to ≥ 25% of hematopoietic bone marrow
* Recovered from all prior therapy
* At least 4 weeks since prior investigational anticancer drugs
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00103220
Study Brief:
Protocol Section:
NCT00103220