Your session is about to expire
← Back to Search
Topoisomerase I inhibitors
Trabectedin + Irinotecan for Ewing Sarcoma (U01CA236220 Trial)
Phase 1 & 2
Waitlist Available
Led By Patrick Grohar, MD/PhD
Research Sponsored by Sarcoma Alliance for Research through Collaboration
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing to undergo tumor biopsy
Measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
U01CA236220 Trial Summary
This trial is testing if trabectedin and irinotecan can treat Ewing's sarcoma that has a EWS-FLI1 mutation. Patients will get an infusion of 18F-FLT and have a PET scan to see if the treatment is working.
Who is the study for?
This trial is for patients with relapsed and refractory Ewing sarcoma, specifically the EWS-FLI1 fusion type. Participants must have measurable disease, be in a relatively stable condition (ECOG 0-2 or Lansky ≥50), and agree to undergo tumor biopsies. They should not be pregnant or breastfeeding, have no known therapy that prolongs survival, and must not have used certain drugs like trabectedin.Check my eligibility
What is being tested?
The study tests trabectedin combined with irinotecan for treating Ewing sarcoma. It includes an infusion of a diagnostic agent (18F-FLT) followed by PET scans to assess treatment effects. The first phase has been completed; the second phase is now recruiting participants to further evaluate safety and efficacy.See study design
What are the potential side effects?
Potential side effects may include reactions related to organ function due to trabectedin or irinotecan, issues from biopsy procedures such as bleeding or infection risk, and general chemotherapy-related side effects like nausea, fatigue, hair loss, blood cell count changes.
U01CA236220 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to have a tumor biopsy.
Select...
My cancer can be measured by tests.
Select...
I can care for myself but may not be able to do heavy physical work.
Select...
My Ewing sarcoma has returned, is resistant to treatment, and has a specific genetic feature.
U01CA236220 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I The recommended dose (RD) of trabectedin administered in combination with low dose irinotecan
Phase I Tumor response rate
Secondary outcome measures
Phase 2 To determine anti-tumor activity of the combination trabectedin and low-dose irinotecan
Phase I monitor the avidity of Ewing sarcoma tumors of EWS-FLI1 12-24 hours after trabectedin administration and before irinotecan is administered and before 18F-FLT PET scans
Phase I/Phase 2 Tumor response rate, progression-free survival (PFS), duration of response, and 6-month PFS rate of patients with ES treated with trabectedin and irinotecan.
Other outcome measures
6- month Progression free survival
Duration of Response
Progression free survival
Side effects data
From 2016 Phase 4 trial • 128 Patients • NCT0158899068%
Nausea
63%
Neuropathy peripheral
63%
Fatigue
55%
Diarrhoea
40%
Constipation
31%
Abdominal pain
30%
Palmar-plantar erythrodysaesthesia syndrome
28%
Vomiting
25%
Neutropenia
24%
Mucosal inflammation
23%
Epistaxis
22%
Decreased appetite
20%
Paraesthesia
20%
Insomnia
20%
Alopecia
20%
Gastrooesophageal reflux disease
19%
Headache
18%
Hypertension
17%
Stomatitis
17%
Back pain
16%
Urinary tract infection
16%
Rash
16%
Dysgeusia
14%
Upper respiratory tract infection
14%
Pain in extremity
13%
Mouth ulceration
13%
Thrombocytopenia
13%
Arthralgia
12%
Anaemia
12%
Dysaesthesia
11%
Weight decreased
11%
Oedema peripheral
11%
Musculoskeletal pain
10%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Dysphonia
9%
Depression
9%
Pyrexia
8%
Anxiety
8%
Dry skin
8%
Fall
8%
Proteinuria
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Dehydration
6%
Oropharyngeal pain
6%
Rhinorrhoea
6%
Non-cardiac chest pain
5%
Intestinal obstruction
5%
Hypoalbuminaemia
5%
Nail disorder
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Gastroenteritis
2%
Bronchitis
2%
Lower respiratory tract infection
2%
Pneumonia
2%
Small intestinal obstruction
2%
Anal abscess
2%
Flank pain
2%
Renal failure acute
2%
Confusional state
2%
Febrile neutropenia
2%
Angina pectoris
2%
Enterovesical fistula
1%
Intestinal perforation
1%
Gastrointestinal perforation
1%
Infective exacerbation of chronic obstructive airways disease
1%
Inguinal hernia
1%
Colitis
1%
Colonic obstruction
1%
Muscle abscess
1%
Infected dermal cyst
1%
Clostridium difficile colitis
1%
Ileus
1%
Anal fissure
1%
Gastroenteritis viral
1%
Lobar pneumonia
1%
Pharyngitis
1%
Pneumonia streptococcal
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
1%
Wound infection
1%
Infusion related reaction
1%
Procedural site reaction
1%
Cerebrovascular accident
1%
Hemiparesis
1%
Syncope
1%
Rectal perforation
1%
Catheter site pain
1%
Extravasation
1%
Abscess limb
1%
Radius fracture
1%
Hypomagnesaemia
1%
Hypophagia
1%
Haematuria
1%
Hydronephrosis
1%
Urinary incontinence
1%
Pleural effusion
1%
Pleuritic pain
1%
Musculoskeletal chest pain
1%
Procedural pain
1%
Laceration
1%
Gastrointestinal haemorrhage
1%
Large intestinal obstruction
1%
Transient ischaemic attack
1%
Acute psychosis
1%
Pneumonia aspiration
1%
Jugular vein thrombosis
1%
Orthostatic hypotension
1%
Thrombophlebitis superficial
1%
Device related infection
1%
Ear infection
1%
Enterocolitis infectious
1%
Eyelid infection
1%
Gangrene
1%
Pilonidal cyst
1%
Gastritis
1%
Visual impairment
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab: Phase A and Phase B
U01CA236220 Trial Design
1Treatment groups
Experimental Treatment
Group I: Trabectedin and IrinotecanExperimental Treatment4 Interventions
Trabectedin will be delivered by infusion on day 1 followed by 2 doses on irinotecan delivered by infusion for one hour on day 2 and day 4 of 21 day cycles. Some patients will receive an 18F-FLT Imaging scan prior to the first administration of trabectedin and once after administration of trabectedin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
tumor biopsy
2018
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,619 Total Patients Enrolled
9 Trials studying Ewing Sarcoma
2,243 Patients Enrolled for Ewing Sarcoma
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,531 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
25 Patients Enrolled for Ewing Sarcoma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,470 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to have a tumor biopsy.My organs are working well.You have had an allergic reaction in the past to irinotecan or topotecan or any substances they contain.My cancer can be measured by tests.I can care for myself but may not be able to do heavy physical work.My Ewing sarcoma has returned, is resistant to treatment, and has a specific genetic feature.I have previously been treated with trabectedin or lurbinectedin.I have cancer that has spread to my brain.I have a bleeding disorder.I am not taking any experimental drugs or cancer treatments.I do not have any severe illnesses or infections that are not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Trabectedin and Irinotecan
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Does this research accommodate geriatric participants?
"This clinical trial seeks participants ranging in age from 10 to 99 years old. Additionally, there are 210 studies specifically for minors and 614 studies dedicated towards patients 65 and older."
Answered by AI
In what common medical scenarios is Irinotecan deployed?
"The main therapy used to treat rna-binding protein fus is Irinotecan. Furthermore, this medication has been successful in treating colorectal carcinoma, ovarian cancer, and sarcoma as well."
Answered by AI
Could you provide a summary of the research conducted on Irinotecan?
"In 2002, irinotecan was initially explored at Mayo Clinic in Rochester. Subsequently, 556 clinical trials were concluded with the drug and there are still 278 active research projects - many of them based out of Bethesda, Maryland."
Answered by AI
Is this research experiment currently welcoming participants?
"Yes, according to clinicaltrials.gov this medical trial is presently searching for 45 subjects at 6 sites. It was initially posted on May 1st 2021 and its information has been most recently updated on August 15th 2022."
Answered by AI
Which demographics are being considered for this clinical experiment?
"This medical trial is open to individuals between the ages of 10 and 99 who have been diagnosed with ewing sarcoma. Approximately 45 participants are being sought for this project."
Answered by AI
Are there numerous locations where this experimental research is taking place within the city limits?
"Currently, 6 clinical trial sites are accepting participants for this study located in Bethesda, Boston, Los Angeles and several other cities. To best accommodate your needs it is advised that you choose the closest institution to minimize travel costs."
Answered by AI
Has the FDA sanctioned Irinotecan for usage?
"Irinotecan's safety has only been assessed in minimal capacity, so it was assigned a rating of 1 on our scale from 1 to 3."
Answered by AI
How many individuals have volunteered to take part in this scientific experiment?
"Yes, according to clinicaltrials.gov the research initiative is presently recruiting participants after being initially posted on May 1st 2021 and last updated on August 15th 2022. 45 study volunteers are needed from 6 different centres."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger