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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00026494
Eligibility Criteria:
INCLUSION CRITERIAL:
* Age \> or = 18 years.
* Karnofsky performance score \> or = 60.
* Histopathologic confirmation of the diagnosis of a solid tumor malignancy. The brain metastasis diagnosis per se does not have to be pathologically confirmed if the clinical and neuro radiographic picture is typical.
* MRI (or CT if the patient cannot undergo MRI) evidence of evaluable disease in the brain.
* Absolute neutrophil count \> or = 1,500/mm³. Platelet count \> or = 100,000/mm³.
* Hemoglobin \> or = 10 g/dl.
* BUN and serum creatinine both \< 1.5 times upper limit of normal.
* Total and direct bilirubin both \< 1.5 times upper limit of normal.
* SGOT and SGPT both \< or = 3 times upper limit of normal.
* Alkaline phosphatase \< or = 2 times upper limit of normal.
* At least two weeks must have elapsed from brain biopsy, craniotomy, or other surgery.
* Life expectancy \> or = 8 weeks.
* Patient or their legal guardian or legal next-of-kin must provide written informed consent prior to patient's registration on study.
* At least four weeks must have elapsed from previous external beam radiation therapy, or eight weeks from stereotactic radiosurgery.
* Patients treated with radiosurgery should have evidence of progression at a distant site in the brain, or confirmation of tumor progression by biopsy or PET scan.
EXCLUSION CRITERIA:
* Previous treatment with temozolomide, dacarbazine or vinorelbine.
* Patients who have not recovered from all acute toxicities of prior therapies.
* Patients with evidence of leptomeningeal metastases or primary dural metastases.
* Patients who are poor medical risks because of nonmalignant systemic disease, as well as those with acute infection requiring treatment with intravenous antibiotics.
* Patients whose psychiatric condition would, in the judgment of the principal investigator, make it unlikely that they could adhere to the requirements of the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00026494
Study Brief:
Protocol Section:
NCT00026494