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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT00357318
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven metastatic/unresectable adrenocortical carcinoma or melanoma not amenable to curative surgical or radiation therapy.
* Accrual closed as of 5/27/2009 to patients with renal cell carcinoma
* No squamous cell histology
* No histology in close proximity to a major blood vessel
* No history of or known brain metastases, spinal cord compression, or carcinomatous meningitis
* No new evidence of brain or leptomeningeal disease on screening CT scan or MRI
* ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥100,000/mm³
* Hemoglobin ≥ 10.0 g/dL
* Calcium ≤ 12.0 mg/dL
* Urine protein:creatinine ratio ≤ 0.5 by urinalysis
* Patients with urine protein:creatinine ratio \> 0.5 must have proteinuria \< 1,000 mg by 24-hour urine collection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
* None of the following within the past 12 months:
* Myocardial infarction
* Severe/unstable angina
* Severe peripheral vascular disease (claudication) or procedure on peripheral vasculature
* Coronary/peripheral artery bypass graft
* New York Heart Association (NYHA) grade III-IV congestive heart failure
* Cerebrovascular accident or transient ischemic attack
* Clinically significant bleeding
* Deep venous thrombosis
* Pulmonary embolism
* No ongoing cardiac dysrhythmias of NCI CTCAE ≥ grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to \> 450 msec (males) or \> 470 msec (females)
* No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
* No condition classified as NYHA grade III or IV
* No hypertension that cannot be controlled by medications
* Blood pressure \< 140/90 mm Hg
* No evidence of bleeding diathesis or coagulopathy
* No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
* No history of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan unless without progression on \* MRI or CT for 3 months."
* No significant traumatic injury within the past 28 days
* No serious, non-healing wound, ulcer, or bone fracture
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* No known HIV or AIDS-related illness
* No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation.
* Recovered from prior radiation therapy, surgery, or other prior therapy
* No prior bevacizumab or sunitinib malate (SU11248)
* Other antiangiogenic therapies allowed
* No prior tyrosine kinase inhibitor of the VEGF receptor or bevacizumab for patients with metastatic renal cell carcinoma
* No major surgical procedures or open biopsy within the past 28 days
* No core biopsy within the past 7 days
* No radiation therapy or systemic therapy within the past 4 weeks
* No concurrent full-dose anticoagulants (e.g., warfarin)
* Concurrent low-dose anticoagulation (e.g., prophylactic port patency) allowed
* No concurrent treatment on another clinical trial
* No other concurrent investigational drugs
* No concurrent major surgery
* No other concurrent anticancer agents or therapies, including chemotherapy, biological response modifiers, hormonal therapy, surgery, palliative radiation therapy, or immunotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00357318
Study Brief:
Protocol Section:
NCT00357318