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 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT00052403
Eligibility Criteria:
Inclusion Criteria
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective treatment exists
* Measurable or evaluable disease
* Must have clinical or radiological evidence of disease
* Disease must be accessible to biopsy and imaging studies
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* No prior bleeding disorder
Hepatic
* Bilirubin no greater than 1.2 mg/dL
* alanine aminotransferase test (ALT) and Aspartate Aminotransferase (AST) no greater than 2.5 times upper limit of normal (ULN)
* Prothrombin time (PT)/ partial thromboplastin time (PTT) no greater than ULN
Renal
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* Willing to be premedicated for delayed contrast-enhanced MRI
* No prior claustrophobia
* No dementia or altered mental status that would preclude informed consent
* No other uncontrolled concurrent illness
* No ongoing or active infection
* No psychiatric illness or social situations that would preclude study compliance
* No immunodeficiency
* HIV negative
* Must be willing to receive blood products
* No thyroid disease
* Thyroxine and thyroid-stimulating hormone no greater than ULN
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior immunotherapy
Exclusion Criteria Chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* Prior taxanes allowed
* No concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy except:
* Concurrent hormonal replacement therapy
* Concurrent medication for maintaining castrate status in patients with progressive hormone refractory prostate cancer
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
* No prior radiotherapy to more than 25% of the bone marrow
* No concurrent radiotherapy
Surgery
* More than 4 weeks since prior surgery
Other
* No other concurrent investigational or commercial agents or therapies for the malignancy
* No other concurrent antitumor therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00052403
Study Brief:
Protocol Section:
NCT00052403