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 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT00024492
Eligibility Criteria:
-Disease Characteristics-
Advanced (local and/or metastatic) histologically documented solid tumors
Disease is not considered responsive to available conventional modalities or treatments
-Prior/Concurrent Therapy-
Must be fully recovered from acute toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline before most recent treatment)
No radiotherapy, treatment with cytotoxic or biologic agents within 3 weeks prior to study entry (6 weeks for mitomycin or nitrosoureas)
At least 2 weeks after any prior surgery or hormonal therapy
Chronic toxicities of grade 1 from prior treatment are permitted
-Patient Characteristics-
ECOG Performance status of 0-2
Must be at least 18 years of age
Must have the following clinical laboratory values: ANC at least 1,500/mm3; Platelets at least 100,000/mm3; Hemoglobin at least 10 g/dL; albumin at least 3.0 mg/dL; Serum creatinine at least 2.0 mg/dL; Total bilirubin not more than upper limit of normal; ALT, AST, and alkaline phosphatase not more than 1.5 x upper limit of normal; LVEF by MUGA scan greater than or equal to the lower limit of normal
Must sign informed consent
No pregnant and/or nursing patients. Women of child-bearing potential must have negative serum or urine pregnancy test within 1 week prior to study entry. Sexually-active patients (both men and women) must use acceptable contraceptive methods.
No active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
No active infection of any kind
No known HIV infection or viral hepatitis
No active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication, or congestive heart failure
No known CNS metastases
No patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication
No patients requiring immediate palliative treatment of any kind including surgery
No patients who have received a high-dose chemotherapy regimen with stem cell support in the previous 6 months
No patients who have received a cumulative anthracycline dose greater than 250 mg/m2 (doxorubicin equivalent)
No patients unwilling or unable to follow protocol requirements
No patients with known hypersensitivity to mitoxantrone or liposomes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00024492
Study Brief:
Protocol Section:
NCT00024492