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.
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.
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 - December 2023
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 - December 2023
Trial Phase
2
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