Study on Chemotherapy With or Without Ganitumab for Newly Diagnosed Metastatic Ewing Sarcoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

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

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

FACILITYZIPCITYSTATE
Children's Hospital of Alabama35233BirminghamAlabama
USA Health Strada Patient Care Center36604MobileAlabama
Providence Alaska Medical Center99508AnchorageAlaska
Banner Children's at Desert85202MesaArizona
Phoenix Childrens Hospital85016PhoenixArizona
Banner University Medical Center - Tucson85719TucsonArizona
Onvida Health Yuma Medical Center85364YumaArizona
CHI Saint Vincent Cancer Center Hot Springs71913Hot SpringsArkansas
Arkansas Children's Hospital72202-3591Little RockArkansas
Kaiser Permanente Downey Medical Center90242DowneyCalifornia

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