Study on Chemotherapy and Radiation for Children with Embryonal Tumor with Multilayered Rosettes
Sponsor: University of California, San Francisco
ClinicalTrials ID:NCT06861244
This clinical trial is exploring the use of chemotherapy and radiation therapy in children newly diagnosed with a rare brain tumor called Embryonal Tumor with Multilayered Rosettes (ETMR). The study aims to find out if these treatments can help control the disease and improve survival rates.
Patient Parameters
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Program Overview
The study is testing a combination of chemotherapy and radiation therapy in children who have been newly diagnosed with Embryonal Tumor with Multilayered Rosettes (ETMR), a rare type of brain tumor. The goal is to see if these treatments can help stop the tumor from growing and improve survival rates. Children will be grouped based on their surgery results and whether the cancer has spread. The study will follow participants for up to two years to monitor their health and the effectiveness of the treatment.
Description
This study is designed to evaluate the effectiveness of chemotherapy and radiation therapy in children with newly diagnosed Embryonal Tumor with Multilayered Rosettes (ETMR). The primary goal is to determine if these treatments can help stop the tumor from growing for at least six months in children who have had their tumors completely removed and have no signs of cancer spreading. Secondary goals include assessing the two-year survival rates and response to treatment in different groups of children, including those with remaining or spreading tumors.
The study will also explore the use of a blood test to monitor the disease and better understand the genetic makeup of ETMR. Children will be assigned to one of four groups based on their surgery results and whether the cancer has spread. They will receive chemotherapy and possibly radiation therapy, depending on their group. The study will follow participants for up to two years to track their health and the effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of Embryonal Tumor with Multilayered Rosettes (ETMR).
- Must provide a tumor sample for analysis.
- Must not have received any prior treatment for the tumor, except for surgery, if in Cohort 1.
- Must not have received prior radiation therapy for the tumor.
- Open to participants of any age.
- Must start chemotherapy within 28 days of surgery.
- Must meet specific health criteria, including:
- Good blood cell counts and organ function.
- Adequate kidney and liver function.
- Controlled seizure disorder, if applicable.
- Must agree to use effective birth control during the study and for four months after.
- Must be able to understand and sign a consent form, with a parent or guardian if necessary.
Exclusion Criteria
- Participants in Cohort 1 who have received any treatment other than surgery.
- Participants receiving other experimental treatments.
- History of severe allergic reactions to similar treatments.
- Uncontrolled health issues.
- Women who are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Francisco | 94143 | San Francisco | California |
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