Recruiting

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

J1S-MC-JV01 - ClinicalTrials.gov - NCT04145349

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 which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer.
How long will I be in the trial?
Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
Email
Recruiting

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

J1S-MC-JV01 - ClinicalTrials.gov - NCT04145349

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 which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer.
How long will I be in the trial?
Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
Email

Key Requirements

Age :

1-29

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

1-29

Sex

All

Participants must

Participant must have relapsed, recurrent or refractory DSRCT

Participant must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at time of enrollment

Participant must have received at least one line of prior systemic treatment at the time of enrollment

Participant must have adequate organ function, including blood, blood clotting, liver, kidney, heart and blood pressure control

Participants must NOT

Participant must not be a candidate for surgical tumor removal at the time of enrollment

Participant must not have already taken ramucirumab

Participant must not have previously progressed on the combined regimen of cyclophos/vinorelbine and must not have known allergies to any of the agents in the regimen

Participant must not be at risk for/have history of serious bleeding/blood clot events; heart problems; blood pressure crises/brain disease

Participant must not be at risk for/have history of stomach/liver problems; fistulas, ulcers, perforations, or abdominal abscesses; non-healing wounds or broken bones

Participant must not have urinary outflow obstruction, Grade 2 hematuria, or non-infectious cystitis at the time of enrollment

Trial Summary

Conditions the trial is for

Soft Tissue Sarcoma, Pediatric Solid Tumors, Pediatric Cancer

What the trial is testing?

Ramucirumab, Cyclophosphamide, Vinorelbine

Could I receive a Placebo?

no

Enrollment Goal

34

Trial Dates

January 2020 - January 2024

Trial Phase

2

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

1-29

Sex

All

Participants must

Participant must have relapsed, recurrent or refractory DSRCT

Participant must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at time of enrollment

Participant must have received at least one line of prior systemic treatment at the time of enrollment

Participant must have adequate organ function, including blood, blood clotting, liver, kidney, heart and blood pressure control

Participants must NOT

Participant must not be a candidate for surgical tumor removal at the time of enrollment

Participant must not have already taken ramucirumab

Participant must not have previously progressed on the combined regimen of cyclophos/vinorelbine and must not have known allergies to any of the agents in the regimen

Participant must not be at risk for/have history of serious bleeding/blood clot events; heart problems; blood pressure crises/brain disease

Participant must not be at risk for/have history of stomach/liver problems; fistulas, ulcers, perforations, or abdominal abscesses; non-healing wounds or broken bones

Participant must not have urinary outflow obstruction, Grade 2 hematuria, or non-infectious cystitis at the time of enrollment

Trial Summary

Conditions the trial is for

Soft Tissue Sarcoma, Pediatric Solid Tumors, Pediatric Cancer

What the trial is testing?

Ramucirumab, Cyclophosphamide, Vinorelbine

Could I receive a Placebo?

no

Enrollment Goal

34

Trial Dates

January 2020 - January 2024

Trial Phase

2

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?