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 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
NCT ID:
NCT00049361
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed extracranial primary malignancy or brain metastases
* At least 1 brain metastasis with at least 1 unresected lesion that is measurable by contrast-enhanced MRI
* No evidence of spinal drop metastases or spread to noncontiguous meninges
* No lymphoma, small cell lung cancer, or germ cell tumor
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* At least 4 months
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin less than 1.5 mg/dL
* SGPT and/or SGOT no greater than 2 times upper limit of normal
Renal
* Creatinine no greater than 1.5 mg/dL
* BUN no greater than 25 mg/dL
Other
* Able to be regularly followed
* No sensory neuropathy greater than grade 2
* No other major medical illnesses that would preclude study
* No neurologic or psychiatric impairments that would preclude study
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No other concurrent chemotherapy during and for 4 weeks after study
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to head or neck
* No prior stereotactic radiosurgery
* Concurrent radiotherapy to extracranial sites of underlying malignancy allowed
Surgery
* Prior craniotomy allowed if completed within the past 10-28 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00049361
Study Brief:
Protocol Section:
NCT00049361