Protocol Addendum J1S-MC-JV01(d) A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor

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Description

The main reason for this study is to help in answering the following research questions: - Whether ramucirumab with cyclophosphamide and vinorelbine can help children and young adults with desmoplastic small round cell tumor (DSRCT). - The safety of ramucirumab and any side effects you might have when you take it along with cyclophosphamide and vinorelbine. This study is being done to learn more about the investigational drug, ramucirumab, for the treatment of DSRCT. Investigational means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA).

Details
Age

Child to Adult

Eligibility

- Patients must be 12 months to 29 years of age at the time of study enrollment. - Patients with relapsed, recurrent, or refractory DSRCT. - Patients must not have received prior exposure to ramucirumab.

Type of Study

Treatment

Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Margaret Macy,  MD

Margaret Macy, MD

Study ID

Protocol Number: 20-2685A

More information available at ClinicalTrials.gov: NCT04145349

Categories

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