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 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT00365768
Eligibility Criteria:
Inclusion Criteria:
* Patients between the age of 5 and 21 years old.
* Patients who demonstrate the ability to complete the assessment instruments at baseline.
* Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of \> or = to 6mg/m2 of vincristine, or \> 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period.
Exclusion Criteria:
* Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis.
* Patients with recurrent disease.
* Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam.
* Patients who have already received \> 8mg/m2 of vincristine, or \> 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent.
* Patients with hepatic encephalopathy or hyperammonemia.
* Patients with a focally abnormal neurologic exam.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
21 Years
Study:
NCT00365768
Study Brief:
Protocol Section:
NCT00365768