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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT03520504
Eligibility Criteria:
Inclusion Criteria:
* Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 60 years old and no menses for 1\> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
* Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology.
* KPS ≥ 60.
* Age ≥ 10 years.
* For adult patient, the patient is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent.
* Patient at reproductive potential must agree to practice an effective contraceptive method.
* Adequate bone marrow function:
* Hemoglobin ≥ 8g/dL
* Absolute neutrophil count ≥500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Exclusion Criteria:
* Patient with multiple, serious major neurologic deficits including encephalopathy.
* Patient with extensive systemic disease and without reasonable systemic treatment options.
* Patient who is unable to undergo MRI brain and spine with gadolinium contrast.
* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT03520504
Study Brief:
Protocol Section:
NCT03520504