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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT00024206
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed advanced solid tumor for which no standard therapy exists
* At least 1 measurable tumor lesion (at least 2 cm) not previously irradiated
* No history of brain metastases
* Negative brain CT/MRI required for patients with signs and symptoms suspicious for brain metastases
* Performance status - ECOG 0-1
* WBC greater than 3,000/mm\^3
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10 g/dL
* No history of bleeding diathesis
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT less than 2.5 times ULN
* Creatinine less than 1.5 mg/dL
* Creatinine clearance greater than 60 mL/min
* No concurrent uncontrolled medical or psychiatric disorders
* No severe iodine allergy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* At least 30 days since prior over-the-counter, anticancer biologic agents (e.g., shark cartilage)
* No concurrent over-the-counter, anticancer biologic agents (e.g., shark cartilage)
* At least 3 weeks since prior cytotoxic or cytostatic agents (6 weeks for nitrosoureas or mitomycin)
* Patients with ECOG performance status 0:
* Any number of prior chemotherapy regimens allowed
* Patients with ECOG performance status 1:
* No more than 3 prior chemotherapy regimens for metastatic or recurrent disease
* The same drug given on a different schedule does not count as a different regimen
* Prior adjuvant chemotherapy for non-metastatic disease or as part of a concurrent chemoradiotherapy protocol is allowed but does not count as part of the 3-regimen limit
* See Disease Characteristics
* See Chemotherapy
* At least 3 weeks since prior radiotherapy to nonindicator lesions
* No concurrent radiotherapy
* At least 24 hours since prior minor surgery (e.g., central venous catheter placement)
* At least 4 weeks since prior major surgery (e.g., laparotomy, thoracotomy, or craniotomy)
* At least 30 days since prior anticancer herbal remedies
* At least 30 days since prior investigational agents
* No concurrent anticancer herbal remedies
* No other concurrent investigational or anticancer medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00024206
Study Brief:
Protocol Section:
NCT00024206