Ramucirumab for Desmoplastic Small Round Cell Tumor

Recruiting in Palo Alto (17 mi)

+89 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for children and young adults with relapsed, recurrent, or refractory Desmoplastic Small Round Cell Tumor (DSRCT). Participants must have tried at least one systemic treatment before, not be eligible for surgery, and have adequate organ function. They should not have severe infections, recent significant bleeding events or thrombosis, uncontrolled hypertension, certain heart conditions or a history of severe liver disease.

Inclusion Criteria

I cannot have surgery for my condition right now.

My DSRCT cancer has come back or hasn't responded to treatment.

I have had at least one treatment for my condition before, including chemotherapy.

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Exclusion Criteria

Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.

I have a history of serious heart, blood vessel problems, or severe reactions to medications.

I have not had significant bleeding or bleeding disorders in the last 3 months.

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Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Ramucirumab (Monoclonal Antibodies)
Vinorelbine (Vinca alkaloids)

Trial OverviewThe study tests the safety and effectiveness of Ramucirumab combined with chemotherapy drugs Cyclophosphamide and Vinorelbine in treating DSRCT. It's part of a larger protocol aiming to speed up new cancer treatments for young patients. The commitment could exceed 12 months based on individual response to treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Ramucirumab + Cyclophosphamide + VinorelbineExperimental Treatment3 Interventions

Ramucirumab given intravenously (IV), Cyclophosphamide given orally and vinorelbine given IV.

Group II: Cyclophosphamide + VinorelbineActive Control2 Interventions

Cyclophosphamide given orally and vinorelbine given IV.

Cyclophosphamide is already approved in Canada, Japan for the following indications: