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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT00628732
Eligibility Criteria:
Inclusion Criteria:
1. Patients must be less than 22 years of age inclusive
2. Tumor histologies: medulloblastoma/PNET, neuroblastoma, sarcomas, and other pediatric solid tumors for which there is no known effective therapy.
3. Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria.
4. Patients must have a performance status of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients \<= 16 years of age.
5. Patients must have a life expectancy of \>= 8 weeks.
6. Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
7. Patients must not be taking the following medications: growth factors, steroids, and CYP3A4 inducers or inhibitors.
8. Patients must have adequate bone marrow, renal, liver function, pulmonary, or central nervous system function.
9. Must be able and willing to participate in all study procedures, including the ERMBT and pharmacokinetic studies.
10. All patients and/or their parents or legal guardians must sign a written informed consent. (11) All institutional, FDA, and NCI requirements for human studies must be met.
Exclusion Criteria:
1. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
2. Patients with an uncontrolled infection.
3. Allergy to erythromycin
4. Patients who have previously received either cyclophosphamide or topotecan are eligible for this study.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00628732
Study Brief:
Protocol Section:
NCT00628732