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 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT00349167
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumor, meeting 1 of the following criteria:
* Not amenable to standard therapy
* Refractory to conventional therapy
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Life expectancy \> 3 months
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin \> 9 g/L (transfusion independent)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and AST ≤ 2.5 times ULN
* Creatinine clearance ≥ 60 mL/min
* PT/INR or aPTT ≤ 1.1 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 30 days after completion of study treatment
* No significant cardiac comorbidity including any of the following:
* New York Heart Association class III-IV congenital heart failure
* LVEF \< 40%
* Unstable angina
* Myocardial infarction within the past 6 months
* Ventricular arrhythmias requiring drug therapy
* Pacemaker or implanted defibrillator
* No ongoing coagulopathy
* No uncontrolled infection or infection requiring parenteral antibiotics
* No other significant clinical disorder or laboratory finding that would preclude study treatment
* No known HIV positivity
* No known positivity for hepatitis B surface antigen or hepatitis C with abnormal liver tests
* No known allergy to nonplatinum-containing alkylating agents
PRIOR CONCURRENT THERAPY:
* Recovered from prior therapy
* More than 2 weeks since prior hormonal therapy (except for androgen-deprivation therapy)
* More than 4 weeks since prior major surgery
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
* More than 4 weeks since prior radiotherapy
* More than 1 month since prior investigational drugs, therapies, or devices
* No prior radiotherapy to \> 25% of bone marrow
* No prior high-dose chemotherapy, either myeloablative or nonmyeloablative (mini-allogeneic transplant)
* No more than 3 prior myelosuppressive chemotherapy regimens
* Concurrent steroids allowed provided dose is stable for ≥ 2 weeks and clinical condition is stable for 1 month
* Nasal, opthalmologic, and topical glucocorticoid preparations allowed
* Physiologic hormone replacement therapies allowed (i.e., oral replacement glucocorticoid therapy for adrenal insufficiency)
* No concurrent prophylactic hematopoietic growth factors
* No concurrent radiotherapy, including local palliative radiotherapy or systemic radioisotopes
* Radioisotopes for protocol specified positron emission tomography allowed
* No other concurrent investigational agents
* No other concurrent chemotherapy, radiotherapy (including palliative local radiotherapy), hormonal therapy (except for androgen-deprivation therapy), and/or biological therapy (including immunotherapy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00349167
Study Brief:
Protocol Section:
NCT00349167