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Alkylating agents
Ramucirumab for Desmoplastic Small Round Cell Tumor
Phase 1 & 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must not be eligible for surgical resection at the time of enrollment.
Participants with relapsed, recurrent, or refractory DSRCT.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of cr (estimated up to 12 months)
Awards & highlights
Study Summary
This trial is testing a new cancer treatment in children and young adults with DSRCT that has come back or continued after other treatments.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever or chills; damage to blood cells leading to increased infection risk; hair loss; nausea; fatigue; potential bleeding issues due to Ramucirumab affecting blood vessels; and possible harm to organs like the heart or liver from the medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot have surgery for my condition right now.
Select...
My DSRCT cancer has come back or hasn't responded to treatment.
Select...
I stopped my previous cancer treatments at least 7 days ago and have recovered from their side effects.
Select...
My blood pressure is within the normal range for my age.
Select...
My heart is strong, with a good pumping ability.
Select...
My liver functions are within the required range for the study.
Select...
My kidney function is good, based on tests.
Select...
My blood clotting tests are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to date of cr (estimated up to 12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to date of cr (estimated up to 12 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Complete Response (CR): Percentage of Participants Who Achieve CR
Duration of Response (DoR)
Number of Participants with Anti-Ramucirumab Antibodies
+3 moreSide effects data
From 2016 Phase 3 trial • 1253 Patients • NCT0116897346%
Fatigue
36%
Neutropenia
32%
Diarrhoea
30%
Decreased appetite
27%
Nausea
26%
Alopecia
24%
Dyspnoea
23%
Stomatitis
22%
Cough
22%
Anaemia
19%
Epistaxis
18%
Neutrophil count decreased
17%
Oedema peripheral
17%
Constipation
16%
Mucosal inflammation
16%
Pyrexia
14%
Lacrimation increased
14%
Vomiting
14%
Febrile neutropenia
13%
Myalgia
13%
Leukopenia
12%
Peripheral sensory neuropathy
12%
Back pain
11%
Dysgeusia
11%
Hypertension
11%
Insomnia
11%
Headache
11%
Arthralgia
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Rash
7%
Dizziness
7%
Nail discolouration
6%
Dehydration
6%
Pain
6%
Dyspepsia
6%
Haemoptysis
6%
Paraesthesia
6%
Dysphonia
6%
Productive cough
6%
Hyperglycaemia
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Metastatic pain
1%
Lobar pneumonia
1%
Pleural effusion
1%
Pneumothorax
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Syncope
1%
Confusional state
1%
Death
1%
Atrial fibrillation
1%
General physical health deterioration
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramucirumab and Docetaxel
Placebo and Docetaxel
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinorelbine
2013
Completed Phase 4
~2190
Ramucirumab
2017
Completed Phase 3
~5050
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,201,526 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,720 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have surgery for my condition right now.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.My DSRCT cancer has come back or hasn't responded to treatment.I do not have any active severe infections like HIV or hepatitis.My cancer has spread to my brain or spinal cord.I am currently being treated for an active infection.I have had at least one treatment for my condition before, including chemotherapy.I do not have severe liver problems or certain serious digestive or urinary conditions.I have not had major surgery, significant injuries, or a central line placed in the last 28 days.I stopped my previous cancer treatments at least 7 days ago and have recovered from their side effects.My blood pressure is within the normal range for my age.My liver functions are within the required range for the study.My kidney function is good, based on tests.My heart is strong, with a good pumping ability.My blood clotting tests are within normal limits.
Research Study Groups:
This trial has the following groups:- Group 1: Ramucirumab + Cyclophosphamide + Vinorelbine
- Group 2: Cyclophosphamide + Vinorelbine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the elderly included in this trial?
"According to the guidelines for who can participate in this research, 12 months is the youngest age allowed and 29 years old is the oldest age limit."
Answered by AI
Is this clinical trial being conducted at more than one hospital in the state?
"Presently, this study is being conducted in hospitals located in Jacksonville, Fort Myers, Indianapolis and 31 other cities. If you wish to enroll in the trial, try and select a location near to reduce travel time commitments."
Answered by AI
To whom does this trial cater?
"Eligible patients for this study must have desmoplastic small round cell tumor and be between 12 months to 29 years old. This trial is looking to enroll 34 individuals in total."
Answered by AI
How many people are chosen to participate in this experiment?
"The data on clinicaltrials.gov does indicate that this study is actively recruiting participants. The trial was first posted on 1/22/2020 and last updated on 9/8/2022. A total of 34 participants are needed for the trial, which will be conducted at 34 different locations."
Answered by AI
Could you tell me about other research that has been conducted using Ramucirumab?
"Ramucirumab was first studied in 1997 at City of Hope Comprehensive Cancer Center. As of now, 1288 clinical trials have been completed with 955 still active. A majority of these ongoing studies are based in Jacksonville, Florida."
Answered by AI
What are the most common conditions that doctors use Ramucirumab to treat?
"Ramucirumab is commonly used as an effective treatment for multiple sclerosis, leukemia, myelocytic, acute, and malignant neoplasms."
Answered by AI
Are people currently being signed up for this clinical trial?
"Yes, as of 9/8/2022 this clinical trial is still recruiting participants, according to the information posted on clinicaltrials.gov. This study was originally advertised on 1/22/2020."
Answered by AI
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