Study on Chemotherapy With or Without Ganitumab for Newly Diagnosed Metastatic Ewing Sarcoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02306161
This clinical trial is exploring whether adding the drug ganitumab to standard chemotherapy can improve treatment outcomes for patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body.
Patient Parameters
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Program Overview
The purpose of this study is to determine if adding ganitumab, a drug that blocks a pathway important for tumor growth, to standard chemotherapy can help treat Ewing sarcoma that has spread. Standard chemotherapy includes drugs like vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide, which work by killing cancer cells or stopping them from growing and spreading. Researchers want to find out if the combination of ganitumab and chemotherapy is more effective than chemotherapy alone.
Description
The main goal of this study is to see if adding ganitumab to standard chemotherapy improves the time patients live without the cancer getting worse. Researchers will also look at the side effects of adding ganitumab and compare overall survival rates between those who receive ganitumab and those who do not.
The study will also explore how well the cancer responds in the bone marrow and the effects of ganitumab as a maintenance therapy after initial treatment. Researchers will examine various biological markers to see if they affect treatment outcomes.
Participants are randomly assigned to one of two treatment groups. One group receives standard chemotherapy, while the other group receives standard chemotherapy plus ganitumab. Both groups undergo surgery and/or radiation therapy as part of their treatment. After completing the study treatment, participants are followed for 10 years to monitor their health and any long-term effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Ewing sarcoma or a similar tumor that has spread to the lungs, bones, bone marrow, or other areas.
- Metastatic disease is defined as cancer that has spread beyond the primary tumor site.
- Must have adequate tumor tissue available for study.
- Only had a biopsy of the primary tumor, with no attempt at complete removal.
- Meet specific kidney function criteria based on age and gender.
- Have normal liver function and heart function.
- Normal blood sugar levels.
- Must sign informed consent and meet all regulatory requirements.
Exclusion Criteria
- Cancer has only spread to nearby lymph nodes.
- Primary tumor is in the brain or spinal cord.
- Have received prior chemotherapy or radiation therapy.
- Female patients must not be pregnant or breastfeeding and must agree to use contraception.
- Patients with diabetes or on long-term steroid treatment are not eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| USA Health Strada Patient Care Center | 36604 | Mobile | Alabama |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Banner Children's at Desert | 85202 | Mesa | Arizona |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| Onvida Health Yuma Medical Center | 85364 | Yuma | Arizona |
| CHI Saint Vincent Cancer Center Hot Springs | 71913 | Hot Springs | Arkansas |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
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